VP of Quality

October 17, 2020
Emeryville, CA
Job Type


As a key leader of Company, the position will work closely with other functional leaders to define overall GxP (GLP/GCP/GMP) compliance and inspection strategies. You’ll be influential in championing and developing the quality-first mindset into the Company culture while developing and mentoring the Quality organization. Company seeks an experienced, ,nimble, and collaborative leader with maturity, confidence, strategic thinking, and sound judgement/decision making skills.

Quality is the primary guiding principle at the Company.  It is the foundation on which all functions and activities are performed.  Excellence in the management of Quality is fundamental and the foremost aspect upon which the Company team are judged by our patients, caregivers, partners, colleagues, and regulatory bodies.  Our commitment is to go beyond compliance and operate effective development, operations and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of patients and their families living with serious rare diseases.

  • Ensure the quality policy and objectives are integrated with Company culture and understood, implemented, and maintained at all levels of the organization to enable business and compliance objectives to be met. 
  • Ensure quality systems, processes, and procedures are designed to be appropriately compliant for the development, manufacture, testing and timely release, and distribution of quality product, and consistent with the global quality strategy.
  • Meet all relevant regulatory requirements including federal, state and international regulations and applicable standards and guidance.
  • Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality system or product issues.  
  • Develop, administer, and maintain programs and processes to ensure high quality products and compliance with current GxP – Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices.
  • Ensure there are no interruptions to the business due to quality or compliance issues.
  • Design, build, and continuously develop top tier quality operations, systems and compliance teams that scale with Company activities.
  • Interface directly with global regulatory authorities (FDA, EMA, PMDA, and others) to ensure the company is appropriately represented in matters related to quality and  compliance, especially in communications with the regulatory authorities.
  • Develop resource strategies, allocate budget, staff, tools and specialized support necessary for compliant and efficient operations.
  • Provide quality oversight and institute proactive quality management programs in support of continuous inspection-readiness.
  • Direct development and implementation of quality systems to ensure product quality, safety, efficacy, and compliance to applicable Company SOPs, GxP regulations and applicable country specific standards.
  • Work with cross-functional teams to assist in remediation of regulatory issues internally or at CxO sites
  • Lead global quality assurance for clinical development, providing instruction and oversight to guide clinical development programs.
  • Establish required phase appropriate GxP systems for Company, including prioritization and timeline oversight.
  • Ensure GxP compliance of all CROs, CDMOs, and other key third-party contractors
  • Ensure that the commercial supply chain meets all global regulator's expectations during regulatory inspections.
  • Lead periodic senior management reviews to report to the company's leadership team and the BOD on the state of quality and compliance.
  • Develop and monitor quality budgets and oversee expenditures.

Qualifications and Abilities:

  • Minimum of 20 years of biopharma industry experience with increasing responsibilities in Quality, of which at least five years shall have been in a senior role, interacting to affect direction and decision-making within development programs and in regulatory agencies
  • Successful track record of contributing to IND, NDA and MAA submissions and approvals for novel NCE products
  • Strong analytical and problem-solving skills
  • Demonstrated ability to work in a small company environment, playing both a strategic and very hands on role with ability to navigate change and ambiguity
  • Experience in establishing and implementing compliant and efficient quality systems
  • Track record leading, coaching, and mentoring high-functioning, collaborative teams
  • Excellent working knowledge, understanding and experience with practical implementation of FDA and EMA regulations and industry guidelines
  • Experience with cGMP requirements for clinical and commercial products and with US and international regulatory authority inspection requirements.  Track record and first-hand experience hosting pre-approval health authority inspections
  • Exceptional oral and written communication skills to all employee levels, executive leadership and external partners, suppliers, and third parties
  • A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement
  • Bachelor’s Degree in Science or Engineering; Advanced degree highly preferred
  • Must have exceptional leadership skills and extensive experience leading initiatives to drive a culture of compliance within a business.  Must be able to develop, sell, and evangelize key ideas which deliver the compliance objectives for the organization
  • Flexibility and adaptability in constantly changing environments.  Able to lead and compliantly move organizations forward with environmental and organizational ambiguity and without clear and concrete direction
  • Maintain a bias for action and display a sense of urgency.  Must possess exemplary skills in leadership, communication, project management and budget management while maintaining extremely high quality and efficiency standards
  • Willing and able to make sound compliance decisions and act on them with urgency and for the benefit of the Company
  • Exemplify Company core values of Courage, Compassion, Collaboration and Excellence in all activities
  • Willing and able to develop and nurture productive business relationships with colleagues, partners, suppliers, contractors, leaders and subordinates
  • Exemplify excellent interpersonal skills.  Demonstrably able to influence positive outcome without direct reporting authority 
  • Should be able to quickly and accurately evaluate internal and external operations, recommend optimal and compliant decision paths based on those evaluations and lead the organization to successful delivery of business objectives
  • This position is based in the Company Emeryville office
  • Willing and able to travel domestically and internationally, up to 50% of the time
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