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Associate Director, Quality Assurance
1 month ago
Job Summary:
Vera Therapeutics, Inc. is seeking an experienced Associate Director, Quality Assurance to join our team. The successful candidate 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.
Key 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).
Requirements:
- 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.
What We Offer:
- Anticipated base pay range: $170,000 - $208,000.
- Annual performance incentive bonus.
- New hire equity.
- Ongoing performance-based equity.
- Medical, dental, and vision insurance.
- 401k match.
- Flexible time off.
- Paid holidays.
