Sr Mgr Product Quality Integrator

Leiden Bio Science Park; Netherlands; On-site; EUR 120,000 - 160,000; Full time

Job summary

Johnson & Johnson Innovative Medicine (J&J IM) seeks a Senior Manager, Product Quality Integrator for Biotherapeutics to oversee the quality strategy across Early Development to late-stage commercialization. The role requires coordinating Global Quality across CMC/VCT, approving HA submissions, and guiding QA resources for global product integration.

The position is Europe-based (Leiden or Cork) with potential travel up to 10% and leadership of QA teams spanning clinical to commercial lifecycle.

Qualifications

• Bachelor's degree or university equivalent in a technical/scientific discipline such as Pharmacy, Biology, Biochemistry, Biotechnology, or Engineering.
• 8+ years’ experience in pharma/biotech industry.
• Knowledge of cGMP standards, policies and procedures.
• Ability to work across organizational boundaries and influence decision-making.

Responsibilities

• Represents Global Quality on CMC and VCT teams and serves as liaison between VCT and Analytical groups.
• Ensures Quality stage gate deliverables are achieved and QA is integrated across development to launch.
• Reviews and approves filings (IND, IMPD, BLA, NDA, MAA) and supports audits.
• Defines QA resources and leads cross-functional teams for integration from development through lifecycle.
• Drives decision making and problem solving and ensures QA processes (PPQS, CA, PRA, complaints, escalations) are used globally.

Skills

cGMP knowledge

Cross-functional collaboration

Regulatory filings

Risk assessment

Quality systems

Education

Bachelor's degree in Pharmacy/Biology/Biochemistry/Biotech/Engineering

Job description

Johnson & Johnson Innovative Medicine (J&J IM) is recruiting for a Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics. The position will be based at our European sites

The Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow to Late Stage for an assigned group of Biotherapeutic (large molecule) products.

Main responsibilities include but are not limited to:

• Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved.
• Quality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product(s) assigned.
• Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
• Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, device and packaging: development through launch and commercial lifecycle.
• Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, device and packaging;
• Ensures product quality development through Product Lifecycle.
• Supports the sites, represents the sites on CMC and VC teams.
• Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
• Ensures standard Global Quality processes (PPQS, CA, PRA, Complaints, Escalations) are used across sites and facilitates communication throughout Global Quality.
• Presents project updates to Quality Asset Management for Global Quality alignment.
• Drives Decision making and Problem Solving.

Qualifications Required

• A minimum of a bachelor’s degree (or University equivalent) with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration
• A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry
• Knowledge in cGMP standards, policies and procedures
• Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans
• Flexible hours to accommodate US, EMEA and APAC work schedules when necessary, balancing work and personal time is required
• This position will be located in Europe (Cork Ireland, Leiden Netherlands, other) and may require up to 10% domestic and international travel as business demands

Preferred

• A Master’s degree or other advanced degree
• Knowledge of biotech, biotherapeutics and/or sterile pharmaceutical manufacturing
• Experience in technology transfer, process development and/or process validation
• In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies
• Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities

Preferred Skills:

• Business Alignment
• Collaboration
• Compliance Management
• Fact-Based Decision Making
• Good Manufacturing Practices (GMP)
• ISO 9001
• Mentorship
• Organizing
• Quality Auditing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Regulatory Environment
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Technical Credibility