Compliance Solutions Lead

2 weeks ago

Ware, United Kingdom GSK Full time

**Site Name**: USA - Pennsylvania - Upper Providence, Stevenage, Upper Merion, Ware

**Posted Date**: Feb 8 2023

Are you looking for an opportunity to lead the training and strategy delivery of the Portfolio Integration Operations program? If so, this is the role for you.

As Compliance Solutions Lead you will lead and manage the compliance and communication team, risk management process, and reporting of key performance indicators.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- Champion implementation of Internal Control Framework and Change Control
- Subject Matter Expert for Change Control within Medicine Development and Supply (MDS) which includes implementation of an overarching change control oversight model, ensuring KPIs set/tracked, supporting the business to raise changes, and escalation to appropriate governance forums when appropriate.
- Lead cross functional change controls in MDS or other business units when necessary.
- Lead continuous improvement efforts with change control and overall compliance.
- Lead risk management initiatives and mitigations within MDS.
- Exhibit key behaviors and communication styles that are right-sized for stakeholders and project needs.
- Serves as key management contact and will be empowered to make recommendations and decisions where required.
- Provide project management support as needed.
- Foundations in current knowledge of regulatory trends and requirements, adapting practices to business models (dynamic portfolio management) and understanding the operational aspects and impacts of proposed solutions.
- When asked, support special projects and lead compliance activities for identifying, planning and execution quality and/or compliance solutions at local or enterprise levels for GSK assets.
- Understanding stakeholders, building teams, sharing knowledge and know-how and fostering the best decision making possible and at the correct time needed
- Integrating culture, policy and procedure, people and processes, products and patients so that quality, risk and compliance are present in efforts to deliver medicine to patients; and, do so in such a manner as to streamline work without overburdening existing resources.
- Forming positive and productive relationships internal to GSK and with external suppliers.
- Lead integration activities for acquisitions and divestments for CMC areas

**Key Responsibilities**:

- Lead Change Control and Risk Management initiatives in MDS and work collaboratively with line champions to develop and implement a sustainable compliance program.

Internal and external activities may include but are not limited to:

- Working with R&D/GSC counterparts to fulfill OnePharma/OneGSK goals and objectives
- Representing MDS to internal parties and forums
- Lead compliance gap analysis or coordinate cross functional audits.
- Participate and influence corporate compliance.
- Develop and track compliance and change control metrics.
- Lead management monitoring activities for compliance and change control for MDS.
- Develop, manage, implement and communicate right sized compliance programs and continuous improvement initiatives as required
- Provide mentoring and focus-training as required to support platform initiatives.
- Escalating for awareness, consideration and action concerns/ risks which may impact or disrupt delivery of medicines in the pipeline or safety of the people at GSK.

Other duties as assigned

**_ _**_Why you?_**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- BS with 5-10 years of experience with compliance and risk management.

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- Proactive stakeholder management and relationship building with internal or external parties which includes managing multiple or particularly critical stakeholders and influencing the broader agenda outside of your business or organization.
- Leading a cross business/cross functional team.
- Managing a large or very complex organization initiative, driving effective ways of working, interaction and connectivity and ensuring delivery through systems, processes, and people.
- Ability to drive innovative solutions.
- Independently applies knowledge in area of specialization to assignments that involve multiple decision points.
- Applies extensive technical knowledge to form new ideas, concepts and methods; may act as an internal consultant in area of expertise.
- Strong project management skills.
- Deep knowledge of GxP requirements, SOP’s and policies; and, regulatory requirements.
- Capable of managing/executing several projects/activities at different stages of development.
- Anticipates and recognizes potential problems and initiates actions to solve or prevent problems.
- Prioritizes activities to meet project or department objectives.
- Su

  • Lab Group Leader

    4 weeks ago

    Ware, United Kingdom Thermo Fisher Scientific Full time

    **Group Leader - Ware, UK** Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service...

  • Groundworker - East London and Hertfordshire

    3 weeks ago

    Ware, United Kingdom Howells Solutions Limited Full time

    Job title: Groundworker Location: East London and Hertfordshire Salary: £36,000 Social housing Our client a leading housing association, driven by our social purpose where our residents are at the heart of everything we do - more homes, better places, excellent services. Providing an efficient 'right first time' repairs and maintenance...

  • Groundworker - East London and Hertfordshire

    2 weeks ago

    Ware, United Kingdom Howells Solutions Limited Full time

    Job title: GroundworkerLocation: East London and HertfordshireSalary: £36,000 Social housing Our client a leading housing association, driven by our social purpose where our residents are at the heart of everything we do - more homes, better places, excellent services. Providing an efficient 'right first time' repairs and maintenance services to our...

  • Automotive Digital Commercial Lead

    1 day ago

    Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Minimum 3 days per week required on site. The purpose of the s ite GPS Lead role exists to lead the deployment of GSK Production System (GPS) and embed it into the Ware Global Supply Chain site to support delivery of the Business Strategy and improve Business Performance (Innovation, Performance, Trust, and Culture). Ensuring the day to day continuous...

  • Project Manager, After Sales

    1 week ago

    Ware, United Kingdom ATS Automation Full time

    ATS Company: ATS Corporation Requisition ID: 11410 Location: Ware, ENG, GB Dublin, L, IE, . Manchester, ENG, GB Cork, Munster, IE Donnegal, DL, IE #job-location.job-location-inline { display: inline; } Date: May 10, 2024 Project Manager, After Sales & Service Overview ATS’ Global Services team is a dynamic, change-leading team that...

  • Microbiologist - Level 1

    3 weeks ago

    Ware, United Kingdom SRG Full time

    Job Title: Microbiologist Level 1 - Synergy Location: Ware, UKcontract: 12 Month FTCworking pattern: Fully onsiteSalary: Competitive Are you a Microbiology or Biomedical graduate looking for your first role in industry? Or do you already have a background in an industrial micro lab but would like to develop your skills further in a GMP environment?SRG...

  • Microbiologist

    2 weeks ago

    Ware, Hertfordshire, United Kingdom SRG Full time

    Job Title: Microbiologist Level 1 – Synergy Location: Ware, UKcontract: 12 Month FTCworking pattern: Fully onsiteSalary: Competitive Interested in this role You can find all the relevant information in the description below.Are you a Microbiology or Biomedical graduate looking for your first role in industry? Or do you already have a background in an...

  • Production Manager

    3 weeks ago

    Ware, United Kingdom Rapiergroup Full time

    Role summary 2024 (and beyond) is an exciting time for Rapiergroup. With new clients coming on board, and existing clients signing on once more … we have opportunities for those who want to bring their experience and personality to an incredible team. Personable? Dedicated? A Good Egg? If so, we would love to hear from you. You will join an...

  • Senior Project Engineer

    3 weeks ago

    Ware, United Kingdom Wood Full time

    Wood Process & Energy is seeking a Senior Project Engineer to join us on a contract basis. The role will be based on a client site in Ware and would welcome applications from candidates with a strong background in Pharmaceuticals or FMCG. Work scope: Application of Wood and client health and safety standards within the working environment and design...

  • OCTO Big Data Architect IT Consultant Master

    3 weeks ago

    Ware, United Kingdom Morph Enterprise Full time

    100% ONSITE The client seeks an experiencedIT Consultant to support the design development implementation andmaintenance of an enterprise Big Data solution as part of the DataModernization Effort. This role will provide expertise to support thedevelopment of a Big Data / Data Lake system architecture thatsupports enterprise data operations including the...

  • Project Engineer

    3 weeks ago

    Ware, United Kingdom Wood Full time

    Wood Process & Energy is recruiting a Project Engineer to join us on a Staff basis.  The role will be based on a client site in Ware and would welcome applications from candidates with a strong background in Pharmaceuticals or FMCG.  You will be supporting the CapEx delivery of equipment and facilities on a site undergoing consistent and varied...

  • Engineering Student Placement

    4 weeks ago

    Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Head of Engineering, Biologics and Devices Are you energized by a highly visible leadership role that allows you to drive and shape the biologics and Device Manufacture for GSK’s Manufacturing Group? If so, the Head of Engineering, Biologics and Devices role could be an exciting opportunity to explore. This leadership role will provide the single...

  • Microbiology Lab Analyst

    3 weeks ago

    Ware, Hertfordshire, United Kingdom SRG Full time

    Job Title: Microbiologist Level 1 - Synergy Location: Ware, UK contract: 12 Month FTC working pattern: Fully onsite Salary: Competitive Are you a Microbiology or Biomedical graduate looking for your first role in industry? Or do you already have a background in an industrial micro lab but would like to develop your skills further in a GMP...

  • Microbiologist - Level 1

    3 weeks ago

    Ware, Hertfordshire, United Kingdom SRG Full time

    Job Title: Microbiologist Level 1 - Synergy Location: Ware, UK contract: 12 Month FTC working pattern: Fully onsite Salary: Competitive Are you a Microbiology or Biomedical graduate looking for your first role in industry? Or do you already have a background in an industrial micro lab but would like to develop your skills further in a GMP environment?...

  • Microbiology Analyst

    2 weeks ago

    Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    The Quality Assurance Department at the GSK Ware Pharma Supply Chain site is responsible for ensuring that all aspects of the manufacture of products is performed in a controlled manner and meets commitments to international regulatory bodies, as well as the requirements of current Good Manufacturing Practice. The Microbiology Laboratory team works as part...