Head of Business Operational Excellence M/F

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

Description

 

POSITION OVERVIEW:

Regulatory Affairs Business Operations believe talented people deserve a great place to work and excellence in our day-to-day operations enables talented people to do their best work Our Mission and Purpose is to reduce complexity, improve performance and to differentiate value. In doing this we unleash and enable our people to be purposeful and impactful
 

The Business Operational Excellence function works across Gilead Global Regulatory Affairs (GRA) to provide the framework for GRA process development and excellence, controlled documentation development and management and effective learning programs. In addition, leadership of the Incubation Hub will include oversight of all RSQ initiatives involving GRA. The Business Operational Excellence Functional Head will play a leadership role in developing and implementing Global Regulatory Affairs infrastructure, compliance, process, and capability development. The wider Business Operational Excellence team, incorporating Business Process Management and Excellence, the Quality and Compliance Centralized Process Team (CPT) and dedicated staff responsible for Regulatory Learning & Development, will partner closely across Regulatory Affairs and the wider Gilead organization to provide services including, but not limited to GRA business process support, audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications and regions. The team will also identify, lead, and implement ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities (example: Manage Initiatives Portfolio, Manage Capability and Process Frameworks) across the global organization (US, EU, Japan, China, Australia, Canada, Intercontinental and Global Patient Solutions).

RESPONSIBILITIES:

Leads the Regulatory Business Process Management and Excellence Team, incorporating the wider Centralized Process Team (CPT) and Regulatory Learning & Development dedicated staff, with responsibilities for identification, development, refinement and continuous improvement of processes, standards, practices, efficiencies and capabilities within the Regulatory Affairs Department and wider company. Leads the incubation period for new process and departmental initiatives and appropriate RA capabilities (example: Manage Initiative Portfolio, Manage Capability and Process Frameworks). Hires, develops, and retains diverse top talent on the team. Sets clear and elevating goals for the team and individual direct reports. Coaches team on their performance, development, and career interests. Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team. Accountable for the successful oversight and completion of a broad spectrum of regulatory operational activities. Develops collaborations with key Regulatory and cross-functional stakeholders, to analyse and identify key business drivers and work with the Senior Leadership team to prioritise these, before driving implementation of agreed improved initiatives.  Interfaces with key internal business stakeholders and external groups including CONNECT, GLPS, R&D Quality and Medical Governance, and RSQ Outsourcing Ensures suitable resources and skills are in place to deliver the required continuous improvement culture throughout Global Regulatory Affairs. Work with Regulatory functions to develop suitable training programs. Proactively identifies regulatory or related risks/issues and external leadership, governance ensures timely development of mitigation and decision-making forums, including /or contingency plans. Owns and manages budget and resource plans for assigned area and projections and tracking across the Global Regulatory Organization in close collaboration with the Head of Business Operations for Regulatory Affairs. Ensures team's work complies with established practices, policies, and processes, and any regulatory or other requirements. Ensures suitable processes are in place for Global Regulatory Affairs to function efficiently and in compliance and tracking through to completion. Collaborates with the Head of Vendor Governance and Management Regulatory Affairs and coordinates provision of performance metrics on vendor use across the Global Regulatory Organization.
 

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

Extensive experience leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities. Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products. Experience working as a Global or Regional Regulatory Lead within one or more Gilead therapeutic areas and at varying stages of drug development is strongly preferred.  Multiple years' line management (direct reports) experience. May have experience managing other people leaders (with indirect reports). Proven abilities to independently lead a diverse global team. Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences. Has a strong and established external network of regulatory, other governmental and industry leaders and decision-makers. Extensive experience interacting with and presenting to executives and managing large-scale project budgets and other resources. Experience and proven effectiveness working with regulatory authorities.

Knowledge & Other Requirements

Expert knowledge of the drug development process, global and regional regulatory requirements, and other business functions, as evidenced by proven track record of leading organizations and teams to achieve short- and long-range strategies, plans and objectives. Organizational design and transformation leadership experience. May lead and individually contribute to the maturity of the RA Capability Development Framework Proven ability to influence up, down and across the organization and externally in a collaborative manner. Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives. Exceptional interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives. Strong negotiation and conflict resolution skills. Advanced coaching capabilities to mentor/develop staff. When needed, ability to travel.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


For Current Gilead Employees and Contractors:

Please log onto your to apply for this job.

  • Regulatory Affairs Program Director M/F

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time

    Regulatory Affairs Program Director M/F - 080 Our RA teams are looking for a Program Director based in the UK to pilot and manage Regulatory Affairs outsourcing projects/programs for major clients for which specific dedicated programs and teams are put in place. About us Group 10 Missions You will act as a direct point of contact with those...

  • Business and Operations Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    An exciting opportunity has arisen for a Business and Operations Manager to join the Department of Earth Sciences. The person appointed to this role will support the Head of the Department in achieving the strategic aims and objectives of the Department. They will be responsible for the overall co-ordination and effective running of the Department, this...

  • Head Chef

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hungry Horse Full time

    Company DescriptionAs a Head Chef , you'll make sure everything in the kitchen runs smoothly during a busy service. You'll know how to get the best out of your team by encouraging and supporting them to work well together, ensuring every dish served is of the highest standards. Join us at Hungry Horse, where the drinks are always flowing and the plates are...

  • Head of Operations

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom ic resources Full time

    This is an exciting opportunity for a Head of Operations or a Operations Manager who is taking the next step in their career. As the Head of Operations you will join a company based in Cambridge to drive growth and excellence in their operations team. As the Head of Operations, you will play a pivotal role in managing contract manufacturers, logistics,...

  • M&E Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom CBRE-2 Full time

    M&E Manager Job ID 188119 Posted 23-Oct-2024 Service line GWS Segment Role type Full-time Areas of Interest Engineering/Maintenance Location(s) Cambridge - England - United Kingdom of Great Britain and Northern Ireland Job Title: M&E Manager Role Purpose M&E Manager responsible for management of all Mechanical, Electrical, and...

  • M&A Tax Manager

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom Michael Page Full time

    This exciting opportunity involves managing and leading on a variety of M&A Tax projects within the Professional Services industry in Cambridgeshire. The M&A Tax Manager will be responsible for developing and implementing tax strategies for mergers and acquisitions.Client DetailsOur client is a large organisation in the financial practice sector,...

  • M&E Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Talent Speakers Colombia SAS Full time

    Job Description Vacancy SummaryJob Title: M&E Manager (Mechanical Bias)Job Type: PermanentJob Ref: #1200Location: CambridgeshireStart Date: ASAPSalary: c£65k-£70k basic plus competitive package inc car or allowance, pension, health, bonus etc.Company & Project: A successful Main contractor with an excellent reputation in Cambridge is seeking to recruit a...

  • Team Member M&S

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom SSP Deutschland GmbH Full time

    About UsOperating in nearly 40 countries across the world, our purpose is to be the best part of the journey. Whether our customers are flying abroad on holiday, heading off on a business trip or commuting to work by train, we aim to offer them food and drink experiences that meet their many different tastes and needs.What You'll Get from UsOur commitment to...

  • M&A Tax Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom PRO-TAX RECRUITMENT LIMITED Full time

    Join a Leading Team as an M&A Tax ManagerAre you looking for a career path that offers real progression? As part of this dynamic M&A tax team, you'll not only elevate your skills but also access outstanding opportunities for development and growth. Here's what you can expect:Expand Your Expertise: Deepen your M&A skills while working with a broad range of...

  • M&A Tax Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom PRO-TAX RECRUITMENT LIMITED Full time

    Join a Leading Team as an M&A Tax ManagerAre you looking for a career path that offers real progression? As part of this dynamic M&A tax team, you'll not only elevate your skills but also access outstanding opportunities for development and growth. Here's what you can expect:Expand Your Expertise: Deepen your M&A skills while working with a broad range of...

  • Operations Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Birketts LLP Full time

    Birketts is a full service, UK Top 50 law firm. With a heritage spanning 160 years, we have more than 700 lawyers and legal professionals based in Bristol, Cambridge, Chelmsford, Ipswich, London, Norwich and Sevenoaks. We advise businesses, government and public sector organisations and individuals in the UK and internationally across four principal practice...

  • M&E Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom APPLE TECHNICAL RECRUITMENT (UK) LIMITED Full time

    Vacancy Summary Job Title: M&E Manager (Mechnical Bias)Job Type: PermanentJob Ref: #1200Location: CambridgeshireStart Date: ASAPSalary: c£65k-£70k basic plus competitive package inc car or allowance, pension, health, bonus etc. Company & Project: A successful Main contractor with an excellent reputation in Cambridge is seeking to recruit a talented...

  • Apprentice Highways Operative

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom M Group Energy Full time

    About The RoleRight across infrastructure, there's a requirement to not only maintain, but also renew and reimagine. Whatever stage you're at in your career, with us you'll have an opportunity to grow and develop. Delivering essential infrastructure services for life, while being safety first, and client and customer centric in a friendly, fun and respectful...

  • Visual Merchandiser

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom H&M Group Full time

    This is a permanent position offering 39 hours per week. The position is based in the H&M Cambridge store.As a Visual Merchandiser you are responsible for maintaining and creating an environment that inspires our customers to explore their personal style. Implement the visual identity drive Routines Selling and support the Team deliver a Customer First...

  • Head of Estates

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Robinson College University of Cambridge Full time

    Are you an experienced estates professional looking for a leadership role in a prestigious Cambridge college? Robinson College is seeking a highly skilled and strategic Head of Estates to oversee the management, development, and sustainability of our estate. This is an exciting new post with the opportunity to play a key role in shaping the College's future...

  • Department Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom H&M Group Full time

    This is a permanent position offering 39 hours per week. This position is based in the H&M Cambridge storeOur Leaders have the ambition to make our people and business grow. As a Department Manager you are responsible for overseeing a department to support the Sales and Profit of the store and along with your Team deliver a Customer First Experience.Key...

  • Solar O&M Technician

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom JR United Kingdom Full time

    ersg is recruiting for a Solar O&M Technician/Maintenance Engineer on behalf of a major Solar O&M contractor. The role is well-suited to candidates situated in and around Cambridge.Responsibilities:Perform maintenance and operations on solar photovoltaic systems.Utilize working knowledge of medium voltage and power electronics.Ensure optimal performance of...

  • Environmental Health

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom European Semiconductor Manufacturing Company (ESMC) Full time

    Environmental Health & Safety Engineer (m/f/d)European Semiconductor Manufacturing Company (ESMC)Other sector Permanent contract Full-timeDescription...response and fire fighting is a plus.Language Skills:English: Full Professional Proficiency or NativeGerman: BasicMandarin: Nice to haveProfessional Skills:Communication style: concise, data-driven...

  • M&E Design Coordinator

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Technical Moves Full time

    Are you passionate about engineering design and delivering exceptional building projects? We are seeking a highly motivated M&E Design Coordinator to join our dynamic teamAs an M&E Design Coordinator, you'll be at the heart of our design process, ensuring seamless integration of mechanical, electrical, and plumbing systems into building projects. Your...

  • M&A Senior Tax Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom PRO-TAX RECRUITMENT LIMITED Full time

    M&A Senior Tax Manager - Development to PartnershipLocation: Cambridge (Flexible Working From Home)Salary: Up to 85,000 plus car allowance + benefitsAn ambitious and technically strong M&A Senior Tax Manager is required to join one of the most successful deals teams in the UK, who are offering a clear route to progress to Partner.Why join this team?The M&A...