Quality System Manager

Work Schedule

Environmental Conditions

Job Description

Title: Quality System Manager

Schedule: Standard 1st Shift - Mon to Friday

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.

Division/Site Specific Information

Role is based onsite in San Francisco CA and will support our Advanced Therapies business unit of Thermo Fisher Scientific. We accelerate advanced cell therapies for difficult to treat conditions including cancer rare diseases and other illnesses from a newly opened cGMP manufacturing this facility Thermo Fisher Scientific offers customers process and analytical development capabilities as well as clinical and commercial manufacturing services for novel therapies derived from either a patients cells or from a donor source.

Discover Impactful Work

Lead Quality Systems functions: Investigations Change Controls CAPAs Metrics & Trend Reports. Develop and implement Quality Systems aligning with Regulatory and Corporate Standards. Guide team to foster quality culture compliance and improvement. Lead team responsible for Document Control Training Investigations / Deviations Change Controls CAPAs and Metrics & Quarterly Trend Reports.

A Day In the Life

• Guide the Quality Systems team to build a quality-focused collaborative culture emphasizing compliance and continuous improvement.

• Establish a team environment driven with integrity to apply cGMP requirements and company quality requirements for all activities.

• Supervise performance of Investigations / Deviations CAPAs and Change Controls through identification monitoring trending and reporting of key performance indicators.

• Improve each system apply standard methodologies maintain consistency and ensure system integrity in compliance with regulations.

• Build and deliver training in support of implementing Quality Systems related improvements to ensure adherence to requirements in support of compliance and improved performance.

• Ensure Quality Systems related procedures are aligned to Corporate Quality Standards and Guidelines.

• Attend client meetings as Quality Systems representative to provide mentorship and strategic approach when required.

• Host and facilitate daily huddles and weekly review boards in support of driving the performance of Quality Systems.

• Ensure timely issuance of Quarterly Trend Reports to proactively identify trends and have action plans in place to address them.

• Support Regulatory Inspections Corporate Audits and Client Audits specific to the functions within the Quality Systems team. Talk to auditors during inspections to ensure information is provided in a timely accurate and complete manner.

• Perform as Site System Owner for Trackwise (i.e. support troubleshooting provide support to end users).

• Maintain Trackwise procedures in compliance with all applicable regulations corporate requirements and site procedures.

• Communicate issues that potentially affect product quality/compliance to the attention of Leadership.

• Support special projects as assigned.

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