Associate Director, Quality Assurance - CDMO
$170k/y-$190k/y
Veranova2 days ago
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OnsiteFull-timeDirector
Summary
Veranova is seeking an Associate Director, Quality Assurance - CDMO to manage the Quality Assurance group and ensure compliance at their Devens and North Andover sites.
About the Role
In this role, you will be responsible for implementing and managing cGMP compliant practices, directing day-to-day operations, hosting regulatory audits, interfacing with clients, and leading the development of Quality Assurance personnel. You will also analyze compliance issues, develop SOPs, and ensure supplier qualification.
About You
Required:
- BS or MS in Chemistry or related field.
- Minimum of 10 years of experience in Quality Assurance in an FDA regulated industry.
- Minimum of 5 years of supervisory experience.
- Extensive experience in Analytical and Quality Control support of Active Pharmaceutical Ingredients (API).
- Knowledge of GMP, ICH Q7, and 21 CFR Part 11.
Preferred:
- Experience with SAP, LIMS, and Master Control.
- Project management experience.
- Strong interest in learning and applying new techniques.
Benefits
- Comprehensive health & wellness benefits including mental health resources.
- Generous PTO and holiday pay policies.
- Competitive base salary with performance-based bonuses.
- 401(k) Plan with company match.
- Opportunities for continuous learning and tuition assistance.
Veranova
Veranova is a global leader in process development and manufacturing of active pharmaceutical ingredients (APIs), with a focus on specialty and complex chemistry for small molecules, antibody-drug conjugates, oligonucleotides and peptides. Veranova is headquartered in Devens, Massachusetts and has operations in North America and Europe. For more information, please visit www.veranova.com.
Devens, MA