Quality Operations Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join us as a Quality Operations Manager and contribute to making the world healthier, cleaner and safer. You'll lead quality assurance operations in a GMP environment, ensuring compliance with regulatory requirements while driving continuous improvement. Working with cross-functional teams, you'll provide quality oversight for packaging/distribution operations, incoming inspection, and documentation review. Your guidance will be instrumental in fostering a culture of quality excellence and developing teams dedicated to delivering exceptional results for our customers.

RESPONSIBILITIES:

• Applies cGMP in all areas of responsibility and ensures compliance with 21 CFR Parts 210/211, internal SOPs, and corporate quality standards.
• Provides QA operational oversight of packaging and manufacturing activities, including line clearance, reconciliation, in-process inspections, incoming inspection, and label control.
• Leads and schedules Manufacturing QA staff and Incoming Quality Control staff to ensure effective coverage and compliance support.
• Guides manufacturing and supply chain Quality Record investigations (deviations, CAPA, change control), providing technical expertise to investigators and serving as the QA Operations FAM to ensure timely, thorough, and compliant execution.

• Provides Quality oversight and supports implementation of new manufacturing processes on the floor, equipment, or technologies, ensuring compliance with cGMP requirements.
• Leads QA documentation team to manage QA review of GMP documents, such as packaging batch records, to ensure completeness, accuracy, and cGMP compliance; supports batch disposition decisions in alignment with Quality Systems requirements.

• Makes sound, risk-based quality decisions in partnership with Operations, Supply Chain, and Client Services.
• Exercises Quality authority, in collaboration with Operations and Client Services, to place product or processes on hold and stop manufacturing activities when compliance or product quality risks are identified.

• Escalates quality and compliance risks to Management and Senior Management as appropriate.
• Monitors QA Operations metrics such as batch record review turnaround, Right First Time (RFT), and on-floor compliance trends; implements corrective actions to improve departmental performance and GMP execution.

• Supports regulatory inspections and client audits; ensures inspection readiness within QA Operations and partner departments.
• Identifies process gaps within packaging and QA operations and implements sustainable corrective actions.
• Leads, hires, trains, develops, and coaches QA Operations employees; establishes performance objectives, conducts evaluations, and builds technical capability.
• Maintains staffing plans and ensures adequate QA coverage over day and night shifts to support business needs.
• Other duties may be assigned to meet business needs.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree (B.A./B.S.) from a four-year college or university in a scientific or related discipline required.
• 5+ years of experience in pharmaceutical or regulated manufacturing environment.
• 2+ years of direct supervisory or leadership experience in QA or manufacturing,
• Strong working knowledge of cGMP regulations and pharmaceutical Quality Systems and familiarity with data integrity principles (ALCOA+).
• Experience with deviation investigations, CAPA, change control, and documentation management.
• Demonstrated ability to make independent, risk-based quality decisions.
• Strong organizational, analytical, and leadership skills.
• Work schedule, Monday through Friday, 8 hours per day. Additional overtime (nights) and weekend (Saturday or Sunday) work may be required.
• 25–50% standing and walking on manufacturing/packaging floor to monitor activities. The employee must occasionally li