Manager, Quality Assurance Operations

MANAGER, QUALITY ASSURANCE OPERATIONS

Position Summary:

This position is responsible for managing Quality Assurance Operations activities, including batch disposition and QA activities related to manufacturing and testing of drug (API, bulk drug product, packaged/labeled drug product) for phase 1-3 clinical trials, process validation, product launch, and commercial supplies.

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:

• Required Responsibilities:
  • Document review and batch disposition of API, bulk drug product, and packaged/labeled drug product for commercial and clinical lots (Phase 1-III). Review and approve manufacturing records, including 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
• Possible Responsibilities (depending on experience):
  • Review and approve change controls (CMO and internal) associated with the manufacturing and testing of clinical 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) 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 (or assist in) 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)
  • Generate or assist in generation of Annual Product Review Reports
• Employ the principles of ICH Q8 (Pharmaceutical Development) and Q9 (Risk Management) to the development 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, commercial, 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 4 years of related 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 GMP requirements, and appropriate risk assessment
• Experience in both small molecule and large molecule pharmaceutical industry in a Quality function is preferred.
• Knowledge of ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B)
• Experience with interacting with domestic and international CMOs and CROs in clinical trial and early 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

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

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.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.