Head of Quality

Location
San Francisco, CA, United States
Posted
Nov 21, 2020
Ref
944
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
HEAD OF QUALITY

Position Summary:

This position is the Head of GBT's Quality Unit and is responsible for assuring compliance of the organization through deployment of systems, processes, qualified resources, and oversight supporting of GxP operations in a virtual development and commercial company. Where "x" includes Manufacturing, Clinical, Pharmacovigilance, Laboratory, Distribution Practices.

Collaborate with Operations, Development, Regulatory Affairs, et al leadership to develop systems and provide assurance that regulated activities are performed in accordance with ICH, FDA, EU, and other applicable regulations. Implement phase-appropriate and risk-based solutions for a virtual company through CDMO (Contract Development and Manufacturing Organization) and CRO (Contract Research Organization) oversight.

Develop and implement strategies to implement the GBT Quality Policy: …delivering to patients products that meet established identity, purity, strength, safety, and quality characteristics; conducting clinical trials that protect the rights, safety, confidentiality, and well-being of trial subjects; and ensuring the quality and integrity of the data supporting this enterprise. GBT conducts business ethically and in compliance with applicable quality regulations, codes and standards and strives for continuous improvement.

Communicate risks to product quality, patient safety, or data integrity directly to the Chief Executive Officer and other members of the Senior Management Team as relevant.

The incumbent in this position will establish operational objectives and assignments and delegate assignments to subordinate staff as well as be involved in recommending policy changes and executing company policies.

This position will work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met.

Essential Duties and Responsibilities:
  • Implement and maintain the GBT Quality Manual including creating a Quality and continuous Improvement Culture.
  • Build and maintain infrastructure for Quality to ensure the following:
    • that controls are implemented and completed satisfactorily during manufacturing operations at C(D)MO
    • that developed procedures and specifications are appropriate and followed, including those used by a firm under contract to the manufacturer through external oversight, Quality Agreement, etc.
    • production records are reviewed for compliance with regulatory filing and validated process and ensuring manufacturing investigations are conducted for any unexplained discrepancies
  • Lead regulatory inspections from Health Authorities with document presentation, subject matter expert preparation, and responses to Health Authority
  • Provide a Quality Management Review to inform Senior Management that patient safety, process performance, product quality, and data integrity are managed over the product lifecycle including a timely and effective escalation process to raise appropriate quality issues to senior management for review
    • The results of regulatory inspections and findings, audits and other assessments, and commitments made to regulatory authorities
    • Periodic quality reviews including product quality complaints and recalls
    • Provision, training and/or realignment of resources
    • Potential improvements to the pharmaceutical quality system and related processes
    • Identification of risks to critical trial processes and data at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process)
    • Review the pharmacovigilance system including its quality system in risk-based manner to verify its effectiveness
  • Provide regular updates and timely and effective escalation to the CEO that patient safety, product quality, data integrity and process performance are managed over the product lifecycle. While direct reporting relationship is to the SVP of Operations, Head of QA may escalate directly to the CEO without line management consultation at his/her sole discretion. Topics may include:
    • The results of regulatory inspections and findings, audits and other assessments, and commitments made to regulatory authorities
    • Periodic quality reviews including product quality complaints and recalls
    • Identification of risks to critical trial processes and data at the clinical trial level (e.g., trial design, data collection, informed consent process)
    • Review of the pharmacovigilance system in a risk-based manner to verify its effectiveness
  • Represent Quality at the Senior Leadership team level
  • Provide an adequate number of qualified quality personnel to assure the compliant manufacture, processing, packing, or holding of each product
  • Provide an adequate number of qualified quality personnel to assure the compliant execution of clinical development activities
  • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • Provide systems and resources to ensure compliance of GBT's contractors and suppliers
  • Provide systems and resources to ensure compliance of GBT's IT systems
  • Collaborates with cross-functional stakeholders to identify strategic and operational risks to the quality of products and creates appropriate mitigation and contingency plans
  • Communicate with regulatory agencies
  • Position will require 10-15% travel

Qualifications:
  • A BS, MS, or PhD in a scientific related field and a minimum of 12 years pharmaceutical industry in a Quality function
  • In-depth knowledge and experience implementing phase appropriate quality systems to achieve GxP compliance
  • Strong and clear understanding of GxP and pharmaceutical industry Quality best 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
  • High energy, enthusiasm and excellent leadership and management skills
  • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary.
  • Experience interacting with domestic and international CMOs and CROs in clinical trial and early commercial stage
  • Experience interacting with domestic and international regulatory agencies in clinical trial and early commercial stage
  • Experience in providing quality input to IND, IMPD, NDA, and MAA regulatory submissions and responding to regulators questions

Drive, desire, motivation
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Comfortable executing on multiple projects independently

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.