Quality Manager
4 weeks ago
Job Title: Quality ManagerDuration: 12 monthsLocation: New Brunswick NJ 08903 Comments: 100% onsite , Bachelor degree required in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy. Five years pharmaceutical experience with batch record review, deviation and change control oversight experience. 100% onsiteWork Schedule- Normal business hours. Job Function:Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all Client Co. and applicable Food and Drug Administration (FDA) and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with Client Myers Squibb Co. internal and government (FDA or specific market) requirements and support Quality Services processes (e.g., complaint investigations and change controls). Responsibilities:1. Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP's), authoring and executing Risk Mitigation Plans as needed2. Determines disposition of drug products according to CLIENT and regulatory specifications and standards3. Review change requests generated internally or by External Manufacturer4. Reviews Annual Product Quality Reviews (APQR's) authored by Contract Manufacturers/Packagers and supplement APQR's as required5. Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action6. Review Quality Agreements7. Review and approve product quality complaint investigations8. Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements9. Write, review and implement SOP's to ensure compliance with current CLIENT standard and current Good Manufacturing Practices (cGMP)10. Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)11. Supports product recalls and executes plan as assigned12. Represent Client Myers Squibb during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements13. Assist with preparation of audit observations14. Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate CLIENT and FDA and European Medicines Agency (EMA) cGMP regulations and policies15. Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams Required Competencies:1. Knowledge in solid dosage forms, parenteral technology, biologics or combination products2. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them3. Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA)).4. Good verbal and written communication skills essential5. Excellent interpersonal skills6. Capable to manage multiple priorities7. Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met8. Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems Required Qualification(s) and Desired Experience:1. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent2. A minimum of five (5) years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience3. Experience in a Quality Assurance, Quality Control or equivalent function is required4. Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired CLIENT Biopharma Behaviors:The qualified candidate demonstrates characteristics of our CLIENT BioPharma Behaviors. For more details, refer to InSite CLIENT Website/ People and Performance/CLIENT BioPharma Behaviors.
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