Associate Director, Quality Assurance Operations - Healthcare & Research - Analy

Associate Director, Quality Assurance Operations - Healthcare & Research

Job ID: | Location: Bedford, MA | Contract – 3+ months

Job Description

Associate Director, Quality Assurance Operations (Full-time, Contract). Duration: 3+ months. Location: Bedford, MA.

Responsibilities

• Provide on-the-floor quality operations support across all areas and own the master batch record lifecycle, including final review and approval.
• Provide technical quality guidance as part of teams conducting investigations for complex manufacturing events.
• Review and approve complex deviations and/or investigations that are site specific.
• Actively support and/or lead preparation activities for pre-approval inspections and/or responses to observations.
• Work with product release teams to support issuance of drug substance certificates of conformance and any other disposition required activities.
• Manage CAPA records and serve as CAPA manager for minor or major CAPAs as needed.
• Serve as QA reviewer or impact assessor for downstream purification change control records.
• Support and/or review various reports from quality systems.
• Own various quality procedures and ensure the systems/processes are deployed effectively.

Qualifications

• Excellent technical and regulatory understanding of downstream drug substance purification processes.
• Strong experience with root cause analysis techniques (5‑why, Kepner‑Tregoe, force‑field analysis, DMAIC, fault tree analysis).
• Capability of interpreting and adapting technical reports to support investigations/deviations.
• Demonstrate concise and clear writing of investigation summaries.
• Strong understanding of industry regulations (CFR, USP, EP, JP).
• On‑floor biologics experience in a GMP environment required.
• 7+ years of leadership/management experience in an Operations, Manufacturing Technology or Technical Quality professional role.
• BS/BA in Biological or Chemical Science preferred; 9+ years of relevant experience.
• OR
• Master’s Degree in Biological or Chemical Science; 8+ years of relevant experience.

Pay Range and Benefits

Pay Range: $80.00–$90.00 per hour.

Benefits (eligible): Medical & pharmacy coverage, Dental/vision insurance, 401(k), HSA, FSA, Life Insurance, Pet Insurance, Short‑term and Long‑term Disability, Accident & Critical illness coverage, Pre‑paid legal & ID theft protection, Sick time, EAP.

About Innova Solutions

Founded in 1998, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 B. Through global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients.

Contact

Harish Yadav | Phone: 213‑797‑4030 | Email:

Equal Opportunity Employer

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to an inclusive work environment. If you need a reasonable accommodation, contact or (770) 493‑5588.

#J-18808-Ljbffr