Senior Quality Manager, remote

Thermo Fisher Scientific • Indianapolis, IN

30d • $118,100 - $177,200 • Remote

About The Position

Position: Senior Quality Manager, North America
Location: Remote
When you join Thermo Fisher Scientific, you’ll be part of an exceptionally skilled team where your work will have a real-world impact. Our company is committed to helping customers find cures for cancer, protect the environment, and ensure food safety. This is more than a job; it's a chance to create a difference while achieving your career aspirations. How will you make an impact?
Assuming the role of Senior Quality Manager, you will be essential in upholding a faultless Quality System that aligns with Site Compliance as per regulatory guidelines. You will take the lead on quality initiatives and collaborate with cross-functional teams to facilitate continuous improvement.

Requirements

• B.S. or equivalent experience in a Scientific or a related field is a must
• 10+ years of experience in Quality Assurance, preferably in the Pharmaceutical industry
• 5+ years of people management experience required
• Extensive knowledge of related regulatory requirements
• Outstanding collaboration and communication skills
• Ability to mentor and influence others effectively
• Established track record in guiding and controlling quality systems functions to meet regulatory requirements
• Demonstrated ability to provide compliant and practical solutions to complex product quality issues
• A strong focus on continuous improvement and client-centric approach

Nice To Haves

• ASQ preferred
• QMS experince perferred

Responsibilities

• Provide Quality oversight to all aspects of the Quality System to ensure site compliance with corporate directives, site procedures, and regulatory expectations
• Coordinate change control programs, SOP management, document management, and system administration
• Lead the site Data Integrity program and Computer System Validation
• Lead digital quality projects in accordance with the site's quality strategy
• Coordinate training and Personal Quality Initiative programs
• Develop and implement risk management programs, including communicating risk registers and mitigation strategies to the site Quality Head and SLT
• Participate in regulatory inspections, Corporate audits, and client audits; develop risk mitigation strategies based on findings
• Engage with clients to address their questions and concerns regarding site strategy for controlling product quality through quality systems
• Champion quality initiatives to continuously elevate the quality culture
• Mentor and coach individuals within the quality department to maintain a focus on quality and compliance

Benefits

• We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, 401k, 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.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees