Address
SalaryJob Title: Manager, Quality
Location: Inchinnan
Shift: Mon-Fri 8am - 4:30pm
Key Objectives of the role:
Visible Quality Leader of the Site Quality Management Systems, having responsibilities for assuring internal policies, customer expectations, and regulatory requirements are met.
Understands requirements and processes for Best-in-Class Quality Management Systems and regulatory compliance.
Responsible for site implementation, governance, and maintenance for global centralized ISO certification program, including but not limited to internal audits, management reviews, global documentation, notified body requirements.
Change Leader driving a culture of continuous improvement by employing Practical Process Improvement concepts and managing metrics, tier system issues, reporting and communicating internally to Senior Leaders and diverse audiences.
Closely partner with key pharmaceutical customers to adopt the management system and manufacturing methods to meet aseptic manufacturing standards and applicable 21 CFR part 210/211 and EU requirements including associated training responsibilities.
Management of global centralized Quality Agreement and Compliance Documentation programs.
Supports complex, cross-functional quality and cross-network issues in a variety of subject matter areas and drives resolution and proactive solutions to customer complaints, backorder issues, and disposition of materials.
Minimum Qualifications (must have):
Bachelor’s degree from accredited college/university or equivalent experience with a preference for Science, Engineering, or specialty Biomedical Engineering.
Proven experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
Proven management experience in a complex, biopharmaceutical manufacturing environment.
Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions and to partner with and influence key customers including Finance, R&D, Product Management and the Commercial team.
Strong leadership ability with the capability to leverage and flex diverse resources, respond quickly, understand the impact of changes and decisions, facilitate agreement, build collaborative relationships and focus on customer needs.
Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Lean Six Sigma Black Belt or trained in Lean Sigma/Six Sigma processes.
Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
Compliance with quality standards ((e.g., 21 CFR Part 820, ISO 13485, 9001)
Quality tools e.g. FMEA, Risk Analysis, RCA
Global Systems e.g. TrackWise, AGILE, E1/SAP, LIMS
Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
Preferred Qualifications (nice to have):
Bachelor’s degree in Engineering, Chemistry, Biology or Biomedical Engineering
Experience with Cell Culture manufacturing (dry and liquid) or other similar biological processes. Project Management advanced experience.
Certified Lean Professional or Six Sigma Black Belt
Working Conditions:
Works in an office/lab environment but may be required to spend some time in manufacturing and the warehouse. Must be able to work overtime to complete daily tasks if required.
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
