Senior Manager Commercial Quality UK

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: People Leader

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

Job Description:

J&J Innovative Medicine is recruiting for a Senior Commercial Quality Manager UK to be located in UK.

JOB PURPOSE

The position serves as cluster lead of quality and compliance and oversees the Market Authorisation Holder requirements for licensed products in the UK and Ireland.

The Senior Commercial Quality Manager UK is responsible for the implementation and maintenance of a Quality Management System for pre and post marketing regulated activities and ensures in collaboration with the various leads of regulated functions (e.g. local safety officer (PV), Head of Regulatory, Medical affairs, etc) that the implementation meets the requirements of J&J Quality Policy and that all applicable and global, regional and local regulations are met.

The Commercial Quality Head UK maintains the Business Quality processes and systems to ensure the daily availability of high-quality products and services in the UK and Ireland markets.

ORGANISATION INTERFACES

All functions within J&J Innovative Medicine UK, Ireland and J&J IM EMEA including commercial partners, local safety officer (PV), Head of Regulatory, Medical Information, J&J IM supply Chain, CLS, compliance organizations including JJRC and RDQ, Pharm Global CQ, Cross sector CQ and J&J Corporate Entities.

The Senior Commercial Quality Manager UK interfaces with external Health Authorities including but not limited to MHRA, HPRA, and the UK Home Office. Other external interfaces include 3PL and suppliers.

MAIN DUTIES & RESPONSIBILITIES

• Develop and drive improvement in the Quality System supporting the UK and Ireland operating companies specifically Quality System Management Review, CAPA, Internal Audit, Escalation, Trending, Risk Management, Quality Planning and Failure Investigation.
• QSMR Lead providing in-depth data analysis of product information including complaint data and prepares and delivers the Quality System Management Reviews (QSMR) for all the LOCs under scope.
• Serve as LOC lead on de-risking programs gathering appropriate input to ensure commercial business risks are being addressed and mitigated.
• Carry out strategic planning and development process on a continuous basis.
• Responsible to obtain and maintain the required QMS compliance certificates, licenses and quality agreements for the local operating company, including:
  • Understand, document and explain the legal and quality set-up of the LOC: certificates, delegation of authorities, SLA's, intra company quality agreements, quality agreements with external parties.
  • Establish effective collaborations with other functional areas such as SC QA, CLS QA, RDQ, ESIQ and PV to ensure reliable product supply that meets regulations.
• Accountable for in country product release if mandatory by local regulations.
• Manage the GMP/GDP and product quality aspects.
• Act as 'Responsible Person' (GDP) on Wholesale Dealers Authorization (WDA) as required by EU Directives and Guidelines. The 'Responsible Person' must ensure that the conditions of the WDA are being complied with and must ensure that the quality of the products are being maintained in accordance with the requirements of the appropriate Marketing Authorizations.
• Either personally carry out or delegate activities to ensure that product is stored, handled and distributed according to J&J standards and all applicable regulations. Delegation may be to LOC quality people or to CLS.
• Responsible for reporting of metrics, key performance indicators, working with LOCs to develop recovery plans, providing guidance and oversight to ensure recovery plan commitments are delivered.
• Identification and leadership of strategic and tactical continuous improvement opportunities.
• Proactively partner with commercial and other LOC functions to ensure quality aspects of new launches, delisting and divestures are managed appropriately.
• Work with functional partners to ensure alignment of business quality initiatives with strategic business direction.
• Collaborate with business partners to develop and implement innovative business solutions.
• Perform quality system due diligence and integration activities as required by the business.
• Identify and sponsor local initiatives/projects to increase compliance and to reduce the impact of non-quality non-conformance.
• Identify and sponsor local cross-functional leveraging opportunities for J&J.
• Active engagement with external regulatory authorities, including performing lead and support roles as required for UK and Ireland LOCs during Internal Audits, JJRC Audits and external inspections.
• Provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies.
• Partner on the formulation of responses to JJRC and regulatory agencies in order to address QMS related observations. Collaborate on the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions and related commitments.
• Lead the deployment of QS Enterprise standards, and pharma sector SOPs.
• Standardize and leverage compliance policies, practices and metrics across the LOCs in alignment with cross sector best practice and enterprise standards.
• Ensure emerging regulatory requirements are addressed in a proactive and effective manner.
• Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings.
• Support LOC objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.
• Represent UK and Ireland LOCs as required on quality and business teams at CQ Pharm global level and regional level.
• Responsible for the compliant Complaint Management process and any other activities that ensure Product Quality requirements are met.
• Ensure effective recruitment/organizational development, succession planning for all direct reports.
• Perform financial planning and overall budget management.
• Deliver results by inspiring and mobilizing people and teams while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.
• Empower team to act with speed, agility, and accountability.

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

• Degree in Scientific or associated relevant technical / Quality discipline.
• 10+ years Regulated Industry experience.
• Broad based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance.
• A good working knowledge of related functions such as Regulatory Affairs, Medical information, Pharmacovigilance, Supplier Management, Product Development and Procurement.
• Experience in auditing to regulatory standards.
• Fluent knowledge of English language.
• Demonstrated knowledge of business impact of compliance issues and risk management.
• Demonstrated effective people management.

KEY COMPETENCIES REQUIRED:

• Demonstrate a global and enterprise-wide mindset.
• Excellent communication skills – Both verbal and written.
• Strong Influencing, negotiation and stakeholder engagement skills.
• Insight-driven to uncover risks.
• Cultivate external and internal relationships and partnerships.
• Applies systems-thinking approach to lead solution development.
• Ability to work at both a macro and micro level as required.
• Ability to translate complex situations into simple working solutions.

DESIRABLE:

• Qualified Pharmacist.
• Strong compliance management track record.
• Experience in preparing for & managing external third-party audits in multiple locations.