Sr Mgr Product Quality Integrator

Get 360Pharma; Beerse; Sur place; EUR 110 000 - 140 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a Senior Manager, Product Quality Integrator, to own the quality strategy for biotherapeutics from early development through commercialization and lifecycle management. You will lead QA teams across clinical, DS/DP, device, and packaging and coordinate with CMC/VCT to ensure regulatory readiness and lifecycle quality.

The role requires a bachelor’s degree in a technical field and at least 8 years in pharma/biotech, with strong cGMP knowledge and

Qualifications

• Bachelor’s degree in a scientific/technical field (pharmacy/biology/biochemistry/biotechnology/engineering)
• Minimum of 8 years’ experience in pharmaceutical/biotech industries
• Knowledge of cGMP standards, policies and procedures
• Demonstrated ability to influence across organizational boundaries
• Willingness to travel up to 10% (US/EMEA/APAC)

Responsabilités

• Represents Global Quality on CMC and VCT teams and serves as the single Global Quality contact
• Ensures quality stage gate deliverables are achieved
• Reviews/approves health authority submissions and supports audits
• Defines QA resources for global/local QA of assigned products
• Leads QA teams across clinical, DS/DP, device and packaging from development to launch and lifecycle
• Supports QA communication with External Manufacturers and Business Partners
• Ensures standard Global Quality processes are used and communicated across sites

Connaissances

Leadership

Cross-functional collaboration

Regulatory knowledge

Decision making

Travel readiness

Formation

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

Description du poste

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