Senior Manager, Quality Assurance Operations

Location
San Francisco, CA, United States
Posted
Nov 02, 2018
Ref
374
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR 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 (API, bulk drug product, packaged/labeled drug product) for phase 1-3 clinical trials, process validation, and product launch.

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 to be used in Phase 1, 2, and 3 Clinical Studies. 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 clinical products. Responsible for performing impact assessment related to batch disposition
  • Possible Responsibilities (depending on experience):
    • 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)
  • 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, 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 GMP requirements, and appropriate risk assessment
  • Experience in small molecule pharmaceutical industry in a Quality function.
  • In-depth knowledge and experience implementing phase appropriate procedures and processes related to QA Operations
  • 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 and CROs in clinical trial and early commercial stages
  • Strong and clear understanding of cGMPs and pharmaceutical industry best quality practices
  • Demonstrated leadership in cross-functional and culturally diverse team settings
  • 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.