Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics
The Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics has end‑to‑end accountability for the quality strategy and quality aspects from early development through commercialization in launch and grow for an assigned group of large molecules (biological) products.
All Job Posting Locations
Beerse, Antwerp, Belgium; Leiden, Netherlands; Little Island, Cork, Ireland; Schaffhausen, Switzerland; Zug, Switzerland
Responsibilities
Represents Global Quality on the CMC and Value Chain (VCT) teams. Serves as liaison between VCT and the Analytical group and as the single point of Global Quality contact.
Ensures Quality stage‑gate deliverables are achieved.
Quality reviewer/approver of health authority submissions (IND, IMPD, BLA, NDA, MAA) and associated HA questions, approving filings and questions for secondary filings, and supporting PAI and agency audits for the product(s) assigned.
Defines and oversees the necessary QA resources for global and local QA of assigned products.
Leads a comprehensive quality new product integration team that assures quality throughout clinical, DS, DP, FF & device development through launch.
Ensures product quality development through launch and grow stage.
Supports the sites, representing them on CMC and VC teams.
Supports QA communication/issue resolution with external manufacturers and business partners.
Ensures patients receive the right quality products.
Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
Supports preparation of the criticality analysis per schedule.
Ensures complaints are well managed, issues understood and addressed, and participates in product safety management teams to present complaints trends and topics, coordinating or owning complaints trend signal investigations.
Partners with Product Quality Owner (PQO) Value Optimize & Late Stage to complete Transfer of Ownership activities.
Represents Global Quality on the VCT teams and maintains communication flow between Global Quality and VCT teams.
Brings quality issues to VCT and assists with prioritization of projects and key product decisions.
Supports the business continuity process including VCT strategy and BCP projects.
Reviews proactive product quality scans with VCT and ensures mitigating actions are defined.
Prepares quality sections of Product Strategy and End‑to‑end Value Chain Mapping.
Participates in F2F VCT meetings on PSR and VCM finalization and project prioritization.
Aligns and interfaces JSC Product Strategy with other existing strategies.
Presents project updates to QM for Global Quality alignment.
Escalates issues when appropriate, coordinates and holds escalation meetings, archives minutes and follows up on actions.
Participates and engages on IMTs, supports field/recalls as needed.
Drives decision making and problem solving; coordinates decisions, gives input to new strategies, implements and deploys strategies, and creates product portfolio guidelines on control strategy.
Qualifications
Minimum bachelor’s degree (or equivalent) in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific concentration.
Minimum 8 years’ experience in the pharmaceutical or biotechnology industry.
Knowledge of cGMP standards, policies and procedures.
Demonstrated ability to work across organizational boundaries through presentation, influencing, negotiation and partnering.
Ability to quickly assimilate new technologies, perform risk assessment and develop action plans.
Flexible hours to accommodate US, EMEA and ASPAC work schedules; balancing work and personal time required.
Position can be located in Europe (Ireland, Netherlands, Belgium, Switzerland) and may require up to 10% domestic and international travel.
Preferred
Master’s degree or other advanced degree.
Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing.
Experience in technology transfer, process development and/or process validation.
In‑depth understanding of quality processes/systems, risk management and manufacturing control strategies.
Experience with developing and responding to quality content of regulatory filings, inspections and preparedness activities.
Experience in API and drug product stability.
Johnson & Johnson Family of Companies are equal‑opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status or any other characteristic protected by law.
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