Contract – Manager, Quality Assurance Operations

CONTRACT - MANAGER, QUALITY ASSURANCE OPERATIONS 

Position Summary:

This position is responsible for managing all aspects of Quality Assurance Operations, including batch disposition and management of QA activities related to manufacturing and testing of drug (bulk drug product, 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:

• Document review and batch disposition of bulk drug product and packaged/labeled 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 contract manufacturing organization (CMO) investigations (deviations, out-of-specification/out-of-trend, complaints).  Obtain corrective actions as necessary from CMOs
• Review and approve change controls (CMO and internal) associated with the manufacturing and testing of drug products.  Responsible for performing impact assessment related to batch disposition
• Review and approve test methods, method validation protocols and reports, stability protocols and reports
• Review and approve (or assist in) quality agreements, SOPs, and specifications (raw materials, regulatory starting 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
• Communicate and ensure compliance with Quality objectives, policies and procedures

Qualifications:

• A BS, MS, or PhD in a scientific related field
• Minimum 5 years of experience
• Experience with batch disposition and review of analytical-related documents (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 small molecule pharmaceutical industry in a Quality function 
• In-depth knowledge of ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B)
• 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