Title: Director, Quality Assurance, Drug Product
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Director, Quality Assurance, Drug Product, will report to the Senior Director, Quality Assurance and will be responsible for the QA function for the Drug Product (DP) and Medical Device/ Combination Products. The Director will be responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Products and Devices meet regulatory requirements and internal Vera standards.
Responsibilities:
- Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements
- Responsible for implementing strategies and tactics to promote and maintain GxP compliance
- Lead quality aspects of and provide quality support on DP tech transfers
- Liaise with CMO Quality partners to communicate QA policy and procedures
- Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues
- Responsible for material disposition of commercial and clinical DP/ combination products
- Review executed batch records and associated documentation for material disposition
- Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production
- Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc.
- Provide assistance during both internal and regulatory agency audits as required Perform Person-in-Plant duties, as required
- Participate in Material Review Board as required
- Help define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations
- Act as the Quality representative on assigned product teams to advocate compliance and quality assurance
- Lead for Quality Agreement with external partners
- Support product lifecycle and continued process verification
- Manage one direct report
- Availability for 5-15% travel, both domestically and internationally
Qualifications:
- Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred
- Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting
- Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors
- Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators
- Innovative skills with problem solving and peer influence
- In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements
- Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus
- Experience of working with external partners
- Strong attention to detail is a must
- Excellent interpersonal, written and oral communication skills
- Outstanding organizational skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is starting at $172,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
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