Supervisor, QA Internal Operations

Location: Bedford, NH
Department: Quality Assurance Internal Operations
Reports to: Senior Manager QA Operations
Manages staff: Yes

About the role

The Supervisor, QA Internal Operations leads a team of QA Operations Associates providing 7-day-a-week QA oversight (Quality in Plant – QIP) for clinical and commercial drug products and medical devices. This position ensures compliance with cGMP principles and guidelines, supports quality systems (laboratory control, investigation management, materials management, document control, training), and partners with Manufacturing Operations, Visual Inspection, Materials Management, and other departments to resolve quality issues promptly.

Responsibilities

• Oversee and provide QA support and guidance for daily cGMP manufacturing operations.
• Coordinate with cross-functional teams to improve procedures related to area line clearances, labeling, packaging, and material release.
• Support scheduling activities by monitoring production and visual inspection schedules and reviewing factors that may impact schedules.
• Oversee and assist with product/material labeling, disposition functions, routine manufacturing area line clearances, AQL sampling, and inspection of final package lots.
• Review and approve Blue Mountain documents and work orders.
• Complete staff performance reviews and align personnel goals with corporate initiatives.
• Ensure all pertinent training is assigned and employee training remains in good standing.
• Assist with review of master and executed raw material records and logbooks.
• Review associated QC data to support facility and products.
• Participate in writing or revising SOPs, material control procedures, deviations, CAPAs, and quality investigations.
• Support external client audits and regulatory inspections.
• Obtain gown qualification for sterile manufacturing line clearances.
• Maintain and evaluate current processes and procedures to identify opportunities for continuous improvement.
• Guide personnel on cGMP compliance, internal procedures, regulatory requirements, and industry best practices.
• Assist QA Specialists in batch record reviews and generating Certificates of Analysis (CoAs).
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in a relevant scientific discipline.
• 5+ years of pharmaceutical or biotech industry experience.
• 3+ years of experience in a QA Operations role supporting late-stage clinical and/or commercial production, or equivalent.
• ASQ certification (highly preferred).
• Exceptional organizational skills and attention to detail.
• Ability to make risk-based decisions and resolve issues with minimal guidance.
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in MS Office (Word, Excel).

Preferred Qualifications

• Ability to supervise and lead people in a dynamic, fast-paced work environment.
• Honesty, integrity, respect, and courtesy with all colleagues.
• Creativity and ability to work with minimal supervision while balancing independent thinking.
• Resilience through operational and organizational change.
• Ability to coach, train, and mentor others.
• Experience collaborating with cross-functional staff, management, internal/external clients, and Quality organization members.