Associate Director, Quality Assurance
6 days ago
Job Title: Associate Director, Quality Assurance
Location: Not specified
About Us:
Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases to change the standard of care for patients.
Position Summary:
We seek an Associate Director, Quality Assurance to join our experienced, fast-paced, and collaborative team. The Associate Director, Quality Assurance will report to the SVP, Regulatory Affairs & Quality Assurance and will be responsible for developing and maintaining GMP, GLP, and GCP Quality Management Systems in accordance with FDA, ICH, EMA regulations and guidelines and industry standards.
Responsibilities:
- Develop and maintain Quality Management Systems in compliance with quality standards and guidelines set by regulations and per industry standards.
- Assess and assure quality and regulatory compliance related to GCPs, pharmacovigilance, GLPs, and other related activities performed by employees and vendors.
- Provide QA for GMP, GLP, GCP environment(s) and Document Control.
- Manage the investigation and resolution of Out of Specifications and Deviations.
- Establish or develop GXP policies and/or procedures (e.g., SOPs, work instructions).
- Perform other duties and responsibilities as the company may assign from time to time, including non-Quality assignments, as required.
- Develop and run Quality Governance meetings: Management Review, Quality Council.
Qualifications:
- Bachelor's Degree or higher in biology, chemistry, or related life-sciences discipline.
- Pharmaceutical Industry experience: 8+ years in Quality, including demonstrated leadership in a QA function.
- Prior experience establishing, implementing, and administrating quality systems, including Electronic Document Management Systems (EDMS). Veeva Qdocs and QMS modules experience a plus.
- Ability to lead Quality governance meetings to oversee systems and drive issue resolution.
- Experience leading deviations and investigations into complex quality issues.
- Experience in change control, product complaints, CAPAs.
- Demonstrated understanding of GxP requirements, regulations, development processes, and regulatory inspection procedures.
- Demonstrated creativity, problem-solving, critical analysis, initiative, judgment, and decision-making skills.
- Flexibility in prioritizing work and ability to thrive in a rapidly changing environment.
- Strong ability to work within a team environment and professionally represent Vera to various external stakeholders.
- Excellent interpersonal, written, and oral communication skills.
- Must be able to travel domestically and internationally.
- Ability to operate in alignment with Vera's core values.
Benefits:
Vera Therapeutics offers a competitive total compensation package, including an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. We also offer various benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
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