Quality Assurance Supervisor

The Quality Assurance Supervisor oversees the Quality Assurance (QA) team, manages day-to-day operations, supports quality-related initiatives, and provides guidance to cross-functional teams. This role focuses on managing quality systems, ensuring product quality, developing quality team members, and driving continuous improvement initiatives across the organization.

• Supervisor and mentor QA team members, fostering accountability, compliance, and continuous improvement
• Oversee QA training, ensuring employees are equipped with GMP and the necessary skills
• Set performance objectives for the QA team and provide regular feedback and performance evaluations
• Provide QA oversight of quality events, deviations, CAPAs, and OOS Phase II investigations, make key decisions on product quality, compliance, and regulatory conformance, and elevate significant risks to leadership
• Oversight of customer complaint handling
• Review and/or approve methods, procedures, master records, executed records, reports, and protocols employed in the conduct of cGMP activities
• Support planning and execution of internal audits, external audits, regulatory inspections, and supplier audits by preparing documentation, maintaining records, and tracking responses to findings.
• Assist in maintaining a Supplier Management Program
• Contribute to the Quality Management System (QMS) by developing, implementing, and continuously improving SOPs, training programs, and systems

• Strong interpersonal, verbal, and written communication skills, including technical writing skills
• Ability to lead projects with minimal supervision required; to work independently and in a team-based environment
• Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solving
• Skilled in root cause analysis and implementing effective corrective actions
• High degree of accuracy and strong attention to detail
• Good working computer skills; proficient knowledge of Microsoft Office

• While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, moving parts and vibrations. The noise level in the work environment is usually moderate.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, use hands to handle or feel, and reach with hands or arms. The employee is occasionally required to sit, stoop, kneel, crouch or stand for periods of time. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Monday – Friday, 8:00 a.m. to 5:00 p.m.
• Capability to work extended hours if necessary.

• This position may be required to travel for educational purposes.

• At least 5+ years in a QA function within the pharmaceutical industry, including 2+ years of experience in a leadership role
• Strong leadership abilities with experience mentoring and developing teams
• Previous experience leading inspection readiness and audits
• Strong knowledge of quality systems, deviation/investigation management, risk assessment, and regulatory compliance expectations
• Knowledge of cGMPs or quality regulations, including ICH Q7 and 21 CFR 211 preferred

• Language skills- must be able to read, record and speak the English language, interpret documents such as directions, instructions, safety rules, and procedure manuals in the English language. Must be able to record written information accurately.
• Reasoning ability- must have the ability to apply common sense and understanding to carry out instructions furnished in written, verbal or diagram form. Must be able to deal with simple problems in an organized and efficient manner.

• This position is eligible for all full-time…