Sr. Manager AT QA NPI & QP

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, 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

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Essential Job Duties and Responsibilities

Responsible that the JBV quality systems are applied as per GMP standards within Janssen Biologics. Quality NPD & Launch is the department that supports the manufacturing of New Products and Launch processes. Functions and activities within the department comprise the full spectrum of Quality processes (e.g. Batch Record Review, Product Release, Changes, Non Conformances, CAPAs and complaint handling, Process and Cleaning validation, etc).

As EU-Qualified Person, the jobholder is responsible that commercial and investigational medicinal products (clinical phase I- III) are manufactured, tested, labeled, packed, released, and distributed in compliance with the Marketing Authorization Applications (MAA’s, commercial), IND/IMPD (if present) and CGMP and ATMP’s and Annex 1 and J&J guidelines. The QP should have on-going assurance that the reliance on the Quality Management Systems is well founded;

Principal responsibilities

• Manages, leads & motivates the QA NPI & Launch department and its people to enhance performance and achieve business goals, agreed metrics & budgets
• Manages and improves (leading to acceleration of) the GMP processes to facilitate the production of New Products in Sassenheim and the QC release and stability testing with AT QC.
• Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
• Influences and manages regulatory and corporate expectations and relationships to ensure alignment of the site’s quality systems, projects and programs to maintain GMP compliance, with special focus on NPD & Launch products
• Supports or leads (global) escalations of issues, which have (potential) impact on the delivery of our NPI & Launch products
• Replaces other QA MT members, and the SQH when needed
• Participates in NPI (New Product Introduction), quality and capacity projects, and acts as SME on Quality topics
• Supports inspection readiness programs and manages the process during Quality Regulatory inspections

Additional responsibilities/duties as qualified person

• Reviews and approves the (further processing and final) release (including non-conformances and test results) of Drug Substance lots manufactured at the JBV site (for global distribution) and signs this in the logbook as register. This includes commercial, PPQ and phase 1-3 clinical materials. This is also valid for intermediates shipped to other sites for further processing.
• Approval of High Risk (Global) Change Controls. Represent site in the local change control board.
• Acts as member of the JBV Site CAPA Board. Act as EU-QP in other JSC site escalation boards.
• Manage the Quality escalation and communication of issues that exceed the scope of a single site.
• Acts as the Qualified Person at the JBV site during inspections by Health Authorities. Provides support during internal/Partner audits and inspections by Health Agencies and acts as SME regarding quality oversight of drug substance production process and Qualified Person’s role and responsibilities.
• Partner in the Executive Management Review.
• Reviews and approval of the annual product review. Provide independent review and check any open PQR/APR actions.
• Reviews and approves critical quality documents. Including, but not limited to:
• Quality Agreements
• Periodic Quality reviews (PQR/APR)
• Site Master File
• GMP certificates
• Ensure safety, efficacy and quality of product released by JBV and to ensure compliance with J&J policies, worldwide health regulations and cGMP.
• The QP should have on-going assurance that the reliance on the Quality Management Systems is well founded. Like, but not limited to:
• Take notice of all internal audit reports
• Oversees the post marketing commitments during release for any possible market restrictions
• Assure the required quality agreements are in place
• Continuous training regarding changes to product, processing and GMP

Contacts:

• Operational departments (BU1, BU4and BU5). Purpose: to ensure quality oversight on the clinical and launch operational activities in these departments and to make sure that the execution is done in line with the regulations and company’s policies and guidelines.
• All GMP departments in the site (BTO, FME, Q&CO sub departments, LO, IT etc.). Purpose: strong collaboration with all departments that contribute to the quality of the clinical and launch products at the site.
• J&J contacts: J&J Corporate Compliance, RA departments and other sister sites. Purpose: to ensure alignment with these sites in the areas of the department’s responsibility.
• Regulatory authorities and 3rd Parties. Purpose: ensure the regulatory expectations of the site’s inspection readiness are met and for an effective execution of regulatory/3rd Party inspections
• Finance Management. Purpose: for budget management
• HR. Purpose: all aspects of people management

Minimum Qualification

• University degree at a master level in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering
• Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations
• Minimum 10 years’ experience in Quality of which 5-7 years in a managerial, people leading role
• Deep understanding of ATMP’s, Annex 1 and Sterile Manufacturing principles
• Deep understanding and application of Global Regulatory (cGMP/ICHIFDA/EMA) Guidelines in Operations environment
• Knowledge of/and experience in process development
• Qualification as QP (currently registered on a Manufacturing License in The Netherlands)
• Perfect written and oral communication skills in Dutch and English
• Team player, and ready to take a stand when necessary

Other Requirements

• Excellent written and verbal communication skills with an open, collaborative, interactive leadership style.
• Balanced decision-maker.
• Ability to build and nurture strong and positive relationships.
• The ability to work in a team environment and interact with all levels of the organization.
• Results-driven leader who commits to stretch goals and delivers results.
• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.