Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.

The Director, Site Compliance, is responsible for leadership oversight of compliance and quality governance and improvement initiatives across St. Louis site. This role operates in conjunction with the Site General Manager and Quality Head to ensure compliance with GMP requirement and PSG Quality policies.

You will be responsible for the oversight of strategy and execution of compliance and quality improvement initiatives ensuring representation in site leadership meetings and site strategic meetings. Ensure effectiveness of quality systems and operations to assure compliance to current Good Manufacturing Practices as well as relevant ICH and EU regulations.

You will report to the site General Manager, bea key member of the Site Leadership Team and report indirectly to the Sr. Director of Quality of Biologics Business Unit.

Key Areas of accountability/responsibility

• Ensure accurate resource and budget allocation to site key quality improvement initiatives
• Ensure accurate governance including site and above senior leadership of key quality improvement activities as well as being part of the critical issue pathway
• Be part of the site quality governance and ensure proactive identification of trends and as well as timely definition of preventive actions
• Develop site quality culture
• Responsible for mentoring and coaching the organization on quality and compliance to the cGMP regulations.
• Host the quality council and Quality Management Review in collaboration with Quality Unit
• Leads as a change agent in fast-paced environment to promote flexibility, creativity, and accountability to ensure improvement and compliance.
• Develops effective partnerships with internal staff and external organizations to help formulate and implement proactive regulatory compliance strategies and controls

Knowledge and educational level

• Experienced leader of large operational or quality organizations
• Strong experience working on GMP clinical and commercial operations as well a GMP guidelines including but not restricted to FDA and EMA
• Experience on management of Health Authority Inspection
• > 10 year shown experience of leadership roles in operations and quality
• Sound knowledge on GMP in biotechnology drug substance or similar (Cell and Gene / Aseptic)
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization
• Capable of working collaboratively within a diverse business environment and personnel base
• Strong leadership skills, including the ability to set and coordinate goals, provide positive, constructive, and consistent feedback respectfully, the capability to build positive relationships to improve business results, as well as coach, mentor and develop junior-level staff
• Ability to work effectively within a team in a fast-paced, constantly evolving environment
• Ability to multi-task, prioritize, meet/exceed commitments, and hold themselves, staff, and others accountable
• Strong organizational, planning, and tactical execution/follow-up skills
• Ability to maintain regular and predictable attendance
• Minimum of Bachelor’s degree in Biology, Chemistry, Engineering or related field.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on 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 a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

At Thermo Fisher Scientific, each one of our 70,000 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.

Apply today! http://jobs.thermofisher.com

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.