Quality Assurance Manager
Ardelyx, Inc.
11 days ago
Remote friendly (Waltham, MA)
United States
Operations
Position Summary
- Provide oversight and hands-on support for Quality Assurance (QA) milestones in a fast-paced pharmaceutical environment.
- Support day-to-day quality operations including batch record review, product disposition, investigations, quality agreements, and quality systems support.
- Act as primary QA representative for East Coast operations; provide occasional backup to department management.
Responsibilities
- Support day-to-day east coast teams/operations as primary QA representative.
- Provide QA oversight for CMC activities for development, clinical, and commercial products.
- Review CMO manufacturing documentation (batch records, COAs, packaging records, related GMP documentation) for accuracy, completeness, and compliance.
- Review and approve batch records and product disposition for clinical trials, process validation, registration, and commercial distribution.
- Review and approve development/qualification/validation protocols and reports.
- Partner cross-functionally (CMC, Regulatory Affairs, Supply Chain, external partners) to support quality and compliance across the product lifecycle.
- Provide QA oversight of CMO and supplier activities to meet quality and regulatory expectations.
- Generate Annual Product Quality Report, quality metrics, management review inputs, and KPI reporting.
- Ensure Quality Agreements define GMP responsibilities and oversight expectations.
- Support inspection readiness and internal/external GMP audits.
- Participate in quality systems (deviations, investigations, OOS events, change controls).
- Identify and support continuous improvement in QA processes/systems.
- Ensure compliance with cGMP, ICH, FDA, EU, and other applicable regulations.
Qualifications
- Bachelor’s degree in science or related field; 10+ years progressive GxP Quality Assurance experience in biotechnology (or equivalent).
- CMC experience (DS, DP), with ability to introduce phase-appropriate quality best practices.
- Manufacturing experience as a plant QA (QA PIP).
- Extensive GMP regulatory knowledge (FDA, EU, ICH).
- Experience with QA systems and processes.
- Strong investigational and QA problem-solving skills.
- Strong technical writing skills.
- Advanced software skills (SharePoint, Veeva).
- Provide oversight and hands-on support for Quality Assurance (QA) milestones in a fast-paced pharmaceutical environment.
- Support day-to-day quality operations including batch record review, product disposition, investigations, quality agreements, and quality systems support.
- Act as primary QA representative for East Coast operations; provide occasional backup to department management.
Responsibilities
- Support day-to-day east coast teams/operations as primary QA representative.
- Provide QA oversight for CMC activities for development, clinical, and commercial products.
- Review CMO manufacturing documentation (batch records, COAs, packaging records, related GMP documentation) for accuracy, completeness, and compliance.
- Review and approve batch records and product disposition for clinical trials, process validation, registration, and commercial distribution.
- Review and approve development/qualification/validation protocols and reports.
- Partner cross-functionally (CMC, Regulatory Affairs, Supply Chain, external partners) to support quality and compliance across the product lifecycle.
- Provide QA oversight of CMO and supplier activities to meet quality and regulatory expectations.
- Generate Annual Product Quality Report, quality metrics, management review inputs, and KPI reporting.
- Ensure Quality Agreements define GMP responsibilities and oversight expectations.
- Support inspection readiness and internal/external GMP audits.
- Participate in quality systems (deviations, investigations, OOS events, change controls).
- Identify and support continuous improvement in QA processes/systems.
- Ensure compliance with cGMP, ICH, FDA, EU, and other applicable regulations.
Qualifications
- Bachelor’s degree in science or related field; 10+ years progressive GxP Quality Assurance experience in biotechnology (or equivalent).
- CMC experience (DS, DP), with ability to introduce phase-appropriate quality best practices.
- Manufacturing experience as a plant QA (QA PIP).
- Extensive GMP regulatory knowledge (FDA, EU, ICH).
- Experience with QA systems and processes.
- Strong investigational and QA problem-solving skills.
- Strong technical writing skills.
- Advanced software skills (SharePoint, Veeva).