**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** **Title: Quality System Manager** **Schedule:** Standard 1st Shift - Mon to Friday 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. **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 facility. In 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 patient’s 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. **Keys to Success:** **Education** + Bachelor of Science (B.Sc.) in Chemistry, Pharmacy or a Science related field required. Pharmaceutical analysis field highly preferred. **Experience:** + Must have working experience within quality in the pharmaceutical, or highly regulated industry required. + 3-5 years of supervisory and/or leadership experience required. + 5 years experience performing activities directly related to Investigations / Deviations, Change Controls, CAPAs, monitoring of Metrics, and creation / issuance of Quarterly Trend Reports required. **Knowledge,** **Skills** **and Abilities:** + Exceptional cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality, regulatory and production attitude with an appreciation for client service and the contract manufacturing industry. + Requires PC knowledge and abilities using Microsoft Office (Word, Excel, Access, PowerPoint) products. + Requires interpersonal skills and the ability to lead and work in teams including client services, technical, planning, and financial disciplines. + Requires excellent analytical and organizational skills. **Benefits** We offer competitive remuneration, annual incentive plan bonus scheme, 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. **Compensation and Benefits** The salary range estimated for this position based in California is $112,500.00–$168,750.00. 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: https://jobs.thermofisher.com/global/en/total-rewards Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.