Quality Systems and Compliance Manager

Company Details

Thermo Fisher Scientific

Quality Systems and Compliance Manager

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The Biosciences Division (BID) offers reagents, instruments, and consumables from across the division’s six business units. This division is truly grounded in science with our products offering new hope to cancer patients and so much more. BID is a $2.5 billion business with 4,000+ employees across the globe. Our team serves 480,000 customers with 70,000 products in 180 countries.

How will you make an impact?

Provide direction and management to the functions within Quality Systems & Compliance: Investigations / Deviations, Change Controls, CAPAs, Metrics & Trend Reports, Quality Agreements and Audits. Define, structure, and implement Quality Systems in accordance with GMP and Corporate Quality Standards & Guidelines. Mentor the Quality Systems & Compliance team to create a culture of quality awareness, teamwork, compliance, and continuous improvement with a focus on strong cross functional service throughout the site. Identify and implement tools and processes to drive compliance and sustained performance of the Quality System.

What will you do?

  • Manage team responsible for Investigations / Deviations, Change Controls, CAPAs, Document Control, Metrics & Trend Reports, Quality Agreements, and some Release Functions e.g., C of As.
  • Mentor the Quality Systems team to create a culture of quality awareness, teamwork, compliance, and continuous improvement with a focus on strong cross functional service throughout the site.
  • Establish a team environment driven with integrity to apply Regulatory, ISO 9001 and company quality requirements to applicable activities.
  • Oversee and drive the performance of Quality Systems initiatives linked to Investigations / Deviations, Change Control, and Corrective and Preventative Actions (CAPA) and Audits.
  • Monitor performance of Investigations / Deviations, CAPAs, and Change Controls through identification, monitoring, trending, and reporting of key performance indicators.
  • Drive continuous improvement of each system, adoption of standard methodologies, application of consistency across the site, and ensure integrity of system in compliance with Regulatory, Corporate, and Site requirements.
  • Create and deliver training in support of implementing Quality Systems related enhancements 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 guidance 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 Trend Reports to proactively identify trends and have action plans in place to address them.
  • Host site Corporate Audits and Client Audits. Communicate with auditors during inspections to ensure information is provided in a timely, accurate and complete manner.
  • Manage and execute internal audit program.
  • Be the Site System Owner for Trackwise and Agile and other software (i.e. support troubleshooting, provide support to end users.)
  • Maintain Trackwise and Agile 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 the GMP and ISO 9001 Quality Unit assigned.

How will you get here?

  • Bachelor of Science (B.Sc.) from an accredited college/university in Biological Sciences, Biochemistry, Biotechnology, Biomedical Engineering or other applicable Science.
  • Minimum 6 years proven experience in a Quality position within minimum ISO 9001 environment. Pharmaceutical Industry experience is appreciated.
  • Minimum 3 years supervisory experience.
  • Experience with ISO 9001 and compliance (21 CFR Part 11, FDA 21 CFR Part 820).

Knowledge, Skills, Abilities (Required)

  • Proven understanding of Quality procedures, processes, and guidelines.
  • Experience leading conversations with customers and auditors.
  • Ability to analyze data, summarize results, present data and address feedback.
  • Strong interpersonal and communication skills; written and oral. Ability for technical writing a must.
  • Leadership, delegation, and motivation skills to affect performance and development of individuals in the Quality Systems team and throughout the Quality department.
  • Highly motivated with strong organizational skills.
  • Ability to manage and prioritize multiple tasks and meet deadlines.
  • Self-starter with the ability to work efficiently and independently and to troubleshoot and solve problems.
  • Ability to drive functional technical and operational excellence.
  • Ability to think strategically with the ability to direct the resolution of technical problems using innovative approaches.
  • Working knowledge of data integrity and principles of ALCOA.
  • Detail-oriented and accurate while maintaining a vision of the end result.
  • Work with diverse teams, guide teams through decision making, 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.
  • Highly skilled in Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis.
  • Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).

Knowledge, Skills, Abilities (Preferred)

  • Experience with biological manufacturing processes.
  • Project Management advanced experience.
  • Certified Lean Professional or Six Sigma

To apply for this job please visit www.indeed.com.