Supervisor, Quality Assurance

Quality Assurance Supervisor

The Quality Assurance (QA) Supervisor is responsible for leading and maintaining the Quality Management System (QMS) to ensure compliance with FDA, EMA, ICH, and other global regulatory requirements applicable to biopharmaceutical development, manufacturing, testing, packaging, and distribution. This role provides quality oversight of GMP operations, manages quality systems, supports regulatory inspections, and promotes a culture of quality and continuous improvement across the organization.

The QA Supervisor partners closely with Manufacturing, Quality Control, Regulatory Affairs, Validation, Supply Chain, and Technical Operations to ensure products are manufactured and released in compliance with applicable regulations, company procedures, and quality standards.

This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.

Essential Duties and Responsibilities:

Quality Management System

• Manage and maintain the company's Quality Management System (QMS) in compliance with current Good Manufacturing Practices (cGMP).
• Oversee quality systems including: Deviations, CAPAs (Corrective and Preventive Actions), Change Control, Complaints, Internal Audits, Document Control, Supplier Quality Management, Training Compliance.
• Monitor quality metrics and identify opportunities for continuous improvement.

GMP Compliance and Quality Oversight

• Provide QA oversight for manufacturing, laboratory, packaging, and warehouse operations.
• Ensure compliance with FDA and other applicable regulatory requirements.
• Review and approve GMP documentation, including batch records, protocols, reports, specifications, and SOPs.
• Assess quality risks and ensure appropriate mitigation strategies are implemented.

Investigations and CAPA Management

• Lead and approve investigations related to deviations, out-of-specification (OOS) results, out-of-trend (OOT) results, and customer complaints.
• Ensure timely completion of root cause analyses and effective CAPA implementation.
• Evaluate CAPA effectiveness and monitor closure activities.

Audits and Regulatory Inspections

• Plan, conduct, and manage internal quality audits.
• Support supplier qualifications and vendor audits.
• Prepare the organization for regulatory inspections.
• Act as the primary QA representative during inspections and coordinate responses to audit findings.

Product Release and Documentation

• Ensure proper review and approval of batch production and testing records.
• Support product disposition and release activities in accordance with established procedures.
• Verify the completeness, accuracy, and compliance of GMP documentation.

Leadership and Team Development

• Lead, coach, and develop QA personnel.
• Establish performance goals and development plans for team members.
• Foster a quality-focused culture emphasizing compliance, accountability, and operational excellence.
• Collaboration cross-functionally to drive quality initiatives and business objectives.

Continuous Improvement

• Identify and implement process improvements that enhance quality, efficiency, and regulatory compliance.
• Analyze quality trends and recommend corrective actions to prevent recurring issues.
• Support quality risk management initiatives and inspection readiness programs.

Job Requirements:

• Strong knowledge of: FDA 21 CFR Parts 210, 211, and applicable regulations, IHC guidelines, GMP requirements, Data Integrity principles (ALCOA+), Quality Risk Management.
• Excellent problem-solving and root cause analysis skills.
• Strong written and verbal communication skills.
• Ability to influence and collaborate across functional teams.
• Experience with electronic quality management systems (eQMS) preferred.
• Experience with biologics, cell and gene therapy, monoclonal antibodies, vaccines, or aseptic manufacturing preferred.
• Experience with computerized systems validation and data integrity programs preferred.
• Prior experience in a commercial-stage biopharmaceutical manufacturing environment preferred.

Education and Experience:

• Bachelor's Degree in the Biology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related scientific field.
• A minimum of 7 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or biopharmaceutical industry.
• 3+ years of leadership or supervisory experience.
• Experience working in GMP-regulated manufacturing environment
• Experience supporting regulatory inspections and interactions with health authorities.

Working Conditions:

Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.

Must be able to lift and carry up to 20 pounds.

Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.

Disclaimer:

Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.