Quality Director, Purification & Pharma Analytics (PPA)

Work Schedule

Environmental Conditions

Job Description

Job Description: Director Quality Purification & Pharma Analytics (PPA)

How Youll Make an Impact

Leading quality efforts for PPA the Director reports to the VP of Quality & Regulatory at BPG. They drive a customer-focused quality culture for a multi-site network.

Thermo Fisher Scientific is driven by our core mission: facilitating our clientele to promote global health environmental purity and safety.

This role will be based in Bedford or Chelmsford MA. Drive quality strategy empower teams and collaborate with clients to deliver dependable solutions. Ensure products meet quality standards empowering therapy development.

What You Will Do

• Establish and Lead Strategy Develop and implement the Quality strategy for Purification and Pharma Analytics (PPA) guaranteeing consistency with Bioproduction Group and Company objectives.
• Develop a Culture Emphasizing Quality Promote involvement and responsibility throughout the multi-site PPA network integrating quality into all decisions and procedures.
• Be an Advocate for the Customer Build strong collaborative relationships with customer Quality counterparts understanding their needs and translating them into continuous improvement initiatives.
• Lead through Collaboration Manage matrix relationships across R&D Operations and Commercial teams to ensure end-to-end quality across the product lifecycle.
• Coordinate compliance excellence by ensuring readiness for regulatory inspections (ISO 13485/9001 etc.) audits and industry standards.
• Solve with Diligence and Creativity Apply risk management sophisticated data analytics and root cause problem-solving to prevent issues and enable product reliability.
• Develop and Empower Talent Mentor and coach a diverse team building future leaders in Quality.
• Advance Innovation Partner on new product introductions and continuous improvement projects ensuring quality is crafted into processes and products from the beginning.
• Purification Solutions Uphold meticulous criteria for chromatography and purification products (e.g. POROS and CaptureSelect resins) vital for large-scale biologics and vaccine production.
• Coordinate quality for advanced contaminant and impurity testing solutions (e.g. rapid molecular assays sample prep and automation tools) that enable safe bioproduction.

How Youll Get Here

Education & Experience

• Bachelors degree or higher in Science Engineering or a related field or experience.
• 10 years of experience in the Pharmaceutical Biotech or Medical Device industries with regulated products.
• 5 years leading multi-site or complex organizations in Quality or Operations.
• Consistent record of successful audit/inspection management (FDA ISO or equivalent).
• Experience in customer-facing roles leading complex quality challenges.

Skills and Proficiencies

• Passion for championing an inclusive customer-focused quality culture.
• Business insight: skill to link quality performance to business outcomes.
• Deep knowledge of Quality Management Systems compliance standards (21 CFR Part 820 ISO 13485/9001) and quality tools (FMEA RCA Risk Analysis).
• Strong communication skillsable to engage collaborate and encourage at all levels.
• Experience with enterprise quality systems (TrackWise Agile SAP/E1 LIMS or equivalent).
• Training or certification in Lean/Six Sigma methodologies.

Preferred Qualifications

• Familiarity with Chromatography and Purification Solutions for Bioprocessing or Pharmaceutical Analytics.
• Supplier quality management and procurement oversight.
• Project management experience.
• Knowledge of Lean Production Systems.
• Professional certifications (RAPS ASQ Six Sigma Black Belt) a plus.

Location:

This role is part of the Bioproduction Quality Group and may be based in Bedford or Chelmsford MA.

At Thermo Fisher Scientific each one of our 110000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.

Our total rewards are designed torecognize outstanding performanceandmeet the diverse needsof all our colleagues at every stage of their personal and professional lives. We regularly evaluate and measure our program against established benchmarks to ensure we are delivering the right mix of services and resources and that our participants are receiving a consistently great experience.

Apply today! 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.

ACCESSIBILITY/DISABILITY ACCESS Job Seekers with a Disability: Thermo Fisher Scientific offers an accessibility service for job seekers requiring accommodations in the job application process.

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:

Director