Contract – Senior Manager, Quality Assurance Operations Biologics

CONTRACT – SENIOR MANAGER, QUALITY ASSURANCE OPERATIONS BIOLOGICS

Position Summary:

This position is responsible for leading and managing all aspects of Quality Assurance Operations, including batch disposition and management of QA activities related to manufacturing and testing of biologic drugs (bulk drug product, fill finish, packaged/labeled drug product) for phase 1-3 clinical trials, process validation, and commercial manufacturing. 

GBT places a high value on cooperative team dynamics and a positive, “can-do” work ethic.  The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed.

Essential Duties and Responsibilities:

• Lead a GBT program(s) as the Quality Subject matter Expert (SME) for all quality operation activities for GBT large molecule programs with a Chemistry, Manufacturing, and Controls (CMC) focus
• Document review and batch disposition of cell banks, reference standards, bulk drug product and Drug Product to be used in Phase 1, 2, and 3 clinical studies and commercial.  Review and approve manufacturing records, including associated change controls, investigations (deviations, out-of-specification/out-of-trend), and analytical data
• Review and approve change controls (CMO and internal) associated with the manufacturing and testing of drug products
• Responsible for performing risk assessment related to batch disposition
• Review and approve test methods, method validation protocols and reports, stability protocols and reports
• Key understanding of facility contamination control, aseptic manufacturing and sterility assurance knowledge preferred 
• Review and approve (or assist in) quality agreements, SOPs, and specifications (raw materials, in-process, intermediates, finished product, stability)
• Review and approval of manufacturing process validation protocols and reports
• Establish and maintain phase-appropriate procedures and processes related to QA Operations, that will effectively support the various phases of drug development (Phases I, II, III) and commercial operations
• Employ the principles of ICH Q8 (Pharmaceutical Development) Q9 (Risk Management) and Q10 (Pharmaceutical Quality System) to the development and control of manufacturing processes
• Ensure a systematic approach to development is employed that begins with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management
• Serve as a Subject Matter Expert to support departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality operations
• Must be able to maintain a “big picture” perspective without losing site of the details necessary to meet deliverables and deadlines
• Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork
• As project team member, represent QA on product development teams including pre-clinical, phase 1, 2, and 3 development studies, and manufacturing improvement teams
• Interpret Regulatory Authority regulations, guidelines and policies
• Support regulatory inspections as required
• Communicate and ensure compliance with Quality objectives, policies and procedures
• 10-25% travel expected as part of CMO oversight

 Qualifications:

• A BS, MS, or PhD in a scientific related field
• Minimum 6 years of experience
• Experience with batch disposition and review of analytical-related documents for biologics (test method and stability protocols and reports) is strongly preferred
• Ability to make decisions based on phase-specific cGMP requirements, and appropriate risk assessment 
• Experience in large molecule pharmaceutical industry in a Quality function 
• Aseptic manufacturing of biologic experience preferred
• In-depth knowledge of ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B), and US FDA and EU GMPs
• Experience with interacting with domestic and international CMOs in clinical trial and commercial stages
• Strong and clear understanding of cGMPs and pharmaceutical industry best quality practices
• Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
• Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
• High energy, enthusiasm and excellent leadership and management skills
• Excellent verbal, written, interpersonal, organizational, and communication skills are necessary

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.