Quality - QA Specialist

Work Schedule:

Hybrid with flexible week days onsite.

Job Description:

Working in a cross-functional virtual plant team, this quality manager provides quality oversight of Contract Manufacturing Organizations (CMOs). Primary responsibility is to support management of CMO disposition documentation, assure CMO compliance and applicable current Good Manufacturing Practices (cGMP) and international regulatory standards for biologics drug substance and drug product manufacture, testing, and distribution.

• Perform product disposition activities to ensure timely supply of drug substance, drug product, and finished product that meet commercial customer requirements while ensuring compliance with testing standards, standard operating procedures (SOPs), validation guidelines and regulatory filings
• Author, compile and maintain documentation needed for disposition of the product from Contract Manufacturing Organizations (CMOs)
• Review disposition documentation from CMOs and recommend disposition, escalating potential issues
• Ensure batch documentation relative to CMO materials and products is maintained and archived
• Input required deviation, complaint, change control, and product disposition information into applicable enterprise systems
• Prepare and review of Quality Agreements with external manufacturers and external laboratories
• Manage and report quality metrics in relation to CMO performance
• Prepare and review Annual Product Quality Reviews for client products at CMOs as required
• Work with CMOs and client project teams to ensure pre-approval inspection (PAI) readiness and filing submission readiness for the new products transferred to CMOs or major process changes.
• Assist with reviewing analytical and method protocols and reports for compliance
• Assist with commercialization quality-related activities on the new products transferred or launched to/from CMOs
• Provide quality support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers.
• Support supplier relationship manager, global procurement, supply chain and manufacturing science and technology teams for new projects, technical transfers programs, supplier selection programs, and commercial manufacturing activities
• Review validation documents, deviations, and change controls and elevate any potential compliance gaps
• Escalate issues to senior management to ensure that issues are resolved to support client business and compliance requirements
• Evaluate external quality complaint investigations provided by CMOs
• Ensure maintenance of System, Applications and Products (SAP) Master Data (related to Quality)
• Ability to assess the right balance between business implications, technical considerations and quality decisions
• Strong negotiation, communication and presentation skills across all levels both internal and external to client
• Demonstrated technical expertise in resolution of deviations, development of effective corrective actions and/or preventive actions (CAPA) and use of risk assessments
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met
• Good verbal, written and presentation skills in English
• Proficiency with the use of global systems (e.g. SAP, Microsoft Office)
• Strong strategic and analytical thinking, problem solving and rapid decision making skills
• Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment
• Strong ability in negotiating and influencing without authority in complex, high impact situations
• Demonstrated ability in technical writing, computer knowledge and communication skills is required

• Minimum B.S. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
• Minimum of four (4) years experience in pharmaceutical operations at the manufacturing site
• At least two (2) years in Quality, ideally in product release or pharma project quality
• Experience in aseptic, sterile and biological drug product manufacturing
• Experience in contract manufacturing or contract testing
• Experience with technical writing, ideally authoring investigations, quality risk assessments, process descriptions, or study protocols
• Ability to negotiate and clearly present complex topics both in written and verbally
• Knowledge of combination products manufacturing or finished drug product packaging
• Experience with biological product testing methods/quality control
• Experience with Good Manufacturing Practice (GMP) tools and standard applications: SAP, Quality Management System (QMS) or Verity, Microsoft Office (especially One Note and Visio)