Associate Director, Quality Assurance Operations

Innova Solutions Inc; Bedford (MA); On-site; USD 110,000 - 124,000; Full time

Job summary

Innova Solutions seeks an Associate Director, Quality Assurance Operations in Bedford, MA. This role is full-time contractor for 3+ months with on-site responsibilities on a biologics GMP floor.

You will lead quality operations, master batch record lifecycle processes, and drive investigations into complex manufacturing events. You will review deviations, support pre-approval inspections, issue Certificates of Conformance with product release teams, and guide CAPA management while ensuring

Qualifications

• 7+ years of leadership/management experience in an Operations, Manufacturing Technology or Technical Quality role.
• Strong experience with root cause analysis techniques (5-Why, Kepner-Tregoe, force-field, DMAIC, fault tree).
• Regulatory understanding of CFR, USP, EP, JP in GMP environments.
• On-the-floor biologics experience in a GMP setting.

Responsibilities

• Provide on-the-floor quality operations support and own master batch record lifecycle processes.
• Lead investigations for complex manufacturing events and review deviations.
• Support Pre-approval Inspections and responses to observations.
• Assist product release teams with Certificates of Conformance and other dispositions.
• Manage CAPA records and serve as CAPA manager when needed.
• QA reviewer or impact assessor for downstream purification change controls.
• Review reports from quality systems and ensure deployment of quality procedures.

Skills

Leadership

Root Cause Analysis

Regulatory Knowledge

Biologics GMP on-floor experience

Education

BS/BA in Biological or Chemical Science

MS in Biological or Chemical Science

Job description

Associate Director, Quality Assurance Operations

Position type: Full-time- Contract. Duration: 3+ Months. Location: Bedford, MA

Responsibilities

• Provide on the floor quality operations support for all areas and own the master batch record lifecycle processes 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 may be required to function as a CAPA manager for minor or major CAPA 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.

Requirements

• You will have excellent technical and regulatory understanding of the downstream drug substance purification processes.
• Strong experience with various root cause analysis techniques such as 5-why, Kepner-Tregoe, force-field analysis, DMAIC, fault tree analysis.
• You will demonstrate capability of interpreting and adapting various technical reports in support of Investigations/Deviations.
• Demonstrate capability of writing Investigation summaries in a concise and clear manner.
• Strong understanding of industry regulations such as CFR, USP, EP, JP.
• On the 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 Degree (Biological or Chemical Science Preferred) + 9+ years of relevant experience OR Masters Degree (Biological or Chemical Science) + 8+ years of relevant experience.

Pay Range and Benefits

Pay Range*: $80.00-$90.00 per hour.

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

• Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

About Innova Solutions

Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions

• Named One of America's Best Employers for New Grads by Forbes (2024)
• Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, 2024-2025)
• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
• AWS Advanced Tier Services Partner with 100+ certifications

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https://innovasolutions.workllama.com/atsuser/anonreferafriend and earn $250-$1,000 per referral.

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.

If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [e-mail] or [phone]. Please indicate the specifics of the assistance needed.

Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.

Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.