Manager, Quality GXP Compliance

San Francisco, CA, United States
Nov 14, 2020
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Position Summary:

This Manager Vendor Qualification will be responsible for developing and executing a risk-based vendor lifecycle management program including creating standards and tools for selecting, qualifying, monitoring performance, and retirement of vendors of regulated products or services against defined contracts, Quality Agreements, and regulatory expectations. The Manager Vendor Qualification will facilitate creation of general and vendor specific Key Performance Indicators (KPIs) and work closely with Operations and within Quality to monitor and communicate vendor performance to Operations leadership.

This incumbent will collaborate with Technical and Clinical Operation staff who oversee Contract Organizations to meet the requirements of the Supplier Qualification and Vendor Oversight programs.

This incumbent will provide guidance to define a GxP audit and assessment schedule to ensure vendors and internal departments meet defined procedures and policies, and applicable regulatory expectations.

The incumbent will also monitor emerging regulations, guidance, and current Good Practices to assure the GBT vendor base remains in a state of compliance.

The Quality Vendor Manager will assist in building awareness and understanding of underlying operational and systems strategies to all relevant stakeholders and decision makers, including the tracking of data, identification of improvement projects and management of cross-functional implementation to improve performance of key components and suppliers.

Essential Duties and Responsibilities:
  • Expand and manage a risk-based vendor qualification and oversight program
  • Monitoring and communicating the effectiveness and compliance of the supplier qualification program. Ensuring that the program is conducted according to GBT procedures and applicable domestic and international regulations
  • Develop with Operations vendor evaluation tools that are risk-based, phase-appropriate and scoped of the product or service
  • Support Vendor evaluations related to GxP vendors (CMO, CDMO, CRO, CTL, Software and Services) scope and manage technical and systems assessments, external audits
  • Responsible for the qualification of various types of entities such as CMOS, CROs, CTLs, Distribution Centers, Warehouses for all phases of Clinical Development and Commercial product
  • Responsible for escalating important observations derived from vendor oversight (e.g. external audits)
  • Inform Operations Leadership on the vendor updates and changes (physical, organizational, regulatory status) that may impact product or service
  • Support Data Integrity policies and procedures as applied to vendors
  • Interpret supplier audit reporting, communication, and compliance with requirements and supplier categorization
  • Support the issuance of audit agendas, observations/recommendations, and final audit reports and ensure that audit results are formally recorded and reported and that corrective/preventive actions, if necessary, are documented within the stipulated timelines
  • Ensure that audited departments and suppliers are appropriately informed about the procedures and process and their responsibilities in addressing identified non-conformances and timelines
  • Provide suitable recommendations for internal audit observations; ensure auditees deliver appropriate CAPAs and follow them through to closure. Escalate as appropriate, where resolution of internal audit findings is inadequate
  • Communicate identified risks and potential risks and propose measures to address via the Risk Management and Quality Management Review programs
  • Work with the Vendor Owner to manage the escalation and resolution of risk and compliance issues including vendor performance, security, privacy, approval status and eligibility of Vendors within the GBT GxP scope

  • BS / BA degree in science or engineering discipline is required
  • Has 5+ years of relevant experience (GMP, GCP, GLP) within the pharmaceutical/biotechnology industry
  • Must have proven experience working in a GMP, GCP, GLP environment and interactions with contract organizations, suppliers, service providers and supply chain logistics
  • Strong knowledge of GxP compliance as well as USP, EP, ICH , EU/MHRA and FDA guidelines is required
  • Effective collaboration skills - balancing transparency with discretion to key stakeholders
  • Data and reporting experience to create meaningful metrics and vendor dashboards
  • Organized, detail-oriented, able to perform tasks methodically, and can employ critical thinking in problem-solving
  • Ability to manage multiple simultaneous projects with attention to detail and delivery dates
  • Able to escalate risk with the necessary urgency
  • Quality Risk Management knowledge is preferred
  • Knowledge of current Data Integrity best practices and process implementation is required
  • Strong interpersonal skills with the ability to clearly communicate in writing and verbally
  • Lean / Six Sigma Skills or Supplier Quality Management certification a plus
  • Maintain relevant knowledge of both local and international auditing and appropriate GXP requirements and developments as they impact GBT's SOPs and compliance with GXP and communicate these to QA management, as applicable
  • Direct experience with Regulatory Inspections is preferred

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.