Quality Operations Manager

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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. Youll lead quality assurance operations in a GMP environment ensuring compliance with regulatory requirements while driving continuous improvement. Working with cross-functional teams youll 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:

Bachelors 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.
2550% standing and walking on manufacturing/packaging floor to monitor activities. The employee must occasionally lift and/or move up to 20 pounds.
Vision requirements for this position: Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or less) color vision and the ability to adjust focus.

PREFERRED QUALIFICATIONS

Experience supporting process validation and equipment qualification activities within a GMP manufacturing environment.

Experience supporting FDA EMA or other global regulatory inspections.
Experience in packaging and manufacturing quality oversight within a GMP environment.
Experience in a CDMO or multi-client manufacturing environment.

Experience in clinical trials quality with emphasis on maintaining the blinding of the study.
Extensive familiarity with packaging documentation and batch record review processes.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Other

Relocation assistance is not provided.

Must be legally authorized to work in the United States now and in the future without sponsorship.

Must be able to pass a comprehensive background check which includes a drug screening.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager