Omni Inclusive
D06 - QLTY ASSURANCE METHODS / QA METHODS MGMT - QUALITY MANAGER
Omni Inclusive, New Brunswick, New Jersey, us, 08933
Quality ManagerThis role is 100% OnsiteWork Schedule: Mon - Fri, Business Hours
Position Summary:Provides Quality support to External Manufacturing Operations (EXM) within a cross functional team and Product Disposition reviews for drug products manufactured/packaged by CMOs. Primary responsibility is to support Senior Manager or Associate Directors with management of CMOs, documentation related to product disposition, compliance with all Client Co. (Client) and applicable Food and Drug Administration (FDA) and international regulatory standards. In addition, to ensure that products released from CMOs comply with Client internal and government (FDA or specific market) requirements and support Quality Services processes (e.g. change controls, complaints).
Responsibilities:
1. Support Senior Manager or Director Quality Operations with management of CMOs from a quality andcompliance perspective, including:a. Monitoring quality metricsb. Performing annual risk assessment of CMOs and execute as neededc. Executing Risk Mitigation plans at CMOs as needed2. Compiles disposition documentation needed for release of products from CMOs3. Maintains files for all lots of materials released by Quality Operations, External Manufacturing4. Determines disposition of drug products according to Client and regulatory specifications and standards andescalates potential issues5. Authors Certificates of Analysis, Certificates of Conformance, Release Notifications and other releasedocumentation as required by our customers or regional partners6. Input all required information into applicable enterprise-wide systems (e.g., Systems, Applications and Products(SAP), Document Control and Archiving (DCA)) related to external manufactured/packaged products - lotdisposition, change controls, Corrective Actions and/or Preventive Actions (CAPAs) and deviations7. Assists Quality Operations team with review of change proposals, Quality Agreements, Annual Product QualityReviews, and validation documentation as needed8. Participate in investigations, risk assessments related to manufacturing, packaging and testing issues as needed9. Participate during FDA/other regulatory inspections and corporate Good Manufacturing Practice (GMP)compliance audits as needed10. Follow up with CMO on audit observation responses11. Review / Approve, as required, Product Quality Complaints12. Write, review and implement SOPs to ensure compliance with current Client standard and current GoodManufacturing Practices (cGMPs)
Qualifications:
1. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent2. A minimum of 8 years' experience in pharmaceutical, biologics, biotech or related industry with relevantexperience3. 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 desired5. Knowledge in solid dosage forms, parenteral technology, biologics or combination products6. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them7. Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control andArchiving (DCA))8. Good verbal and written communication skills essential9. Excellent interpersonal skills10. Capable to manage multiple priorities11. Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great senseof urgency while ensuring that all cGMP and Regulatory requirement are met
Position Summary:Provides Quality support to External Manufacturing Operations (EXM) within a cross functional team and Product Disposition reviews for drug products manufactured/packaged by CMOs. Primary responsibility is to support Senior Manager or Associate Directors with management of CMOs, documentation related to product disposition, compliance with all Client Co. (Client) and applicable Food and Drug Administration (FDA) and international regulatory standards. In addition, to ensure that products released from CMOs comply with Client internal and government (FDA or specific market) requirements and support Quality Services processes (e.g. change controls, complaints).
Responsibilities:
1. Support Senior Manager or Director Quality Operations with management of CMOs from a quality andcompliance perspective, including:a. Monitoring quality metricsb. Performing annual risk assessment of CMOs and execute as neededc. Executing Risk Mitigation plans at CMOs as needed2. Compiles disposition documentation needed for release of products from CMOs3. Maintains files for all lots of materials released by Quality Operations, External Manufacturing4. Determines disposition of drug products according to Client and regulatory specifications and standards andescalates potential issues5. Authors Certificates of Analysis, Certificates of Conformance, Release Notifications and other releasedocumentation as required by our customers or regional partners6. Input all required information into applicable enterprise-wide systems (e.g., Systems, Applications and Products(SAP), Document Control and Archiving (DCA)) related to external manufactured/packaged products - lotdisposition, change controls, Corrective Actions and/or Preventive Actions (CAPAs) and deviations7. Assists Quality Operations team with review of change proposals, Quality Agreements, Annual Product QualityReviews, and validation documentation as needed8. Participate in investigations, risk assessments related to manufacturing, packaging and testing issues as needed9. Participate during FDA/other regulatory inspections and corporate Good Manufacturing Practice (GMP)compliance audits as needed10. Follow up with CMO on audit observation responses11. Review / Approve, as required, Product Quality Complaints12. Write, review and implement SOPs to ensure compliance with current Client standard and current GoodManufacturing Practices (cGMPs)
Qualifications:
1. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent2. A minimum of 8 years' experience in pharmaceutical, biologics, biotech or related industry with relevantexperience3. 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 desired5. Knowledge in solid dosage forms, parenteral technology, biologics or combination products6. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them7. Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control andArchiving (DCA))8. Good verbal and written communication skills essential9. Excellent interpersonal skills10. Capable to manage multiple priorities11. Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great senseof urgency while ensuring that all cGMP and Regulatory requirement are met