Senior Manager Commercial Quality UK

Senior Manager Commercial Quality UK, High Wycombe

Client:

Johnson and Johnson

Location:

High Wycombe, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

794f06745957

Job Views:

6

Posted:

02.04.2025

Expiry Date:

17.05.2025

Job Description:

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. 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 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 various leads of regulated functions that the implementation meets the requirements of J&J Quality Policy and that all applicable and global, regional and local regulations are met.

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

1. Develop and drive improvement in the Quality System supporting the UK and Ireland operating companies.
2. Serve as LOC lead on de-risking programs gathering appropriate input to ensure commercial business risks are being addressed and mitigated.
3. Responsible to obtain and maintain the required QMS compliance certificates, licenses and quality agreements for the local operating companies.
4. Accountable for in country product release if mandatory by local regulations.
5. Manage the GMP/GDP and product quality aspects.
6. Act as 'Responsible Person' (GDP) on Wholesale Dealers Authorization (WDA) as required by EU Directives and Guidelines.
7. Responsible for reporting of metrics, key performance indicators.
8. Identification and leadership of strategic and tactical continuous improvement opportunities.
9. Proactively partner with commercial and other LOC functions to ensure quality aspects of new launches, delisting and divestures are managed appropriately.
10. Collaborate with business partners to develop and implement innovative business solutions.
11. Perform quality system due diligence and integration activities as required by the business.
12. Provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies.
13. Lead the deployment of QS Enterprise standards, and pharma sector SOPs.
14. Ensure emerging regulatory requirements are addressed in a proactive and effective manner.
15. Responsible for the compliant Complaint Management process and any other activities that ensure Product Quality requirements are met.
16. Ensure effective recruitment/organizational development, succession planning for all direct reports.
17. Deliver results by inspiring and mobilizing people and teams.

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

1. Degree in Scientific or associated relevant technical / Quality discipline.
2. 10+ years Regulated Industry experience.
3. Broad based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance.
4. Fluent knowledge of English language.
5. Demonstrated effective people management.

KEY COMPETENCIES REQUIRED:

1. Excellent communication skills – Both verbal and written.
2. Strong Influencing, negotiation and stakeholder engagement skills.
3. Ability to work at both a macro and micro level as required.

DESIRABLE:

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

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Created on 02/04/2025 by TN United Kingdom