Quality Director

**_Director, Quality Assurance_**

The Director Quality Assurance, Clinical Trial Division (CTD) is a leadership role responsible for providing leading services in Quality to ensure safe and compliant management of the Allschwil, Switzerland site. The site offers planning, manufacturing, packaging, storing, distribution and label printing expertise. As an experienced Quality leader, you will ensure that the important supplies needed by our customers are manufactured safely for our patients around the world. Ensuring our products are handled and delivered in a compliant manner, with the highest possible value while ensuring adherence to the highest level of quality, performance and reliability standards. The Director, Quality Assurance has full direct operating control of Quality for the site and will lead a team of approximately 80 people across a variety of Quality sub-functional roles.

The Director, Quality Assurance will pursue world class quality, promote a GxP culture and ensure regulatory compliance. Customer engagement is key to the success of the site, and requires direct communication so that they are involved in the process, giving them control in exchange for their attention, and to increase brand awareness and loyalty. This role will be also expected to engage and drive customer satisfaction, managing escalations accordingly.
- Your tasks:
- Advising Quality operations locally to support Business leaders to drive budgeted profit results, establishing objectives and appropriate steps are taken to put preventative actions in place.
- Lead all aspects of Quality functions with direct management of Quality leaders.
- Establish, direct, administer and coordinate current and long-range objectives and activities in accordance with policies, goals and objectives established by the Clinical Trials Division (CTD). Active member the site leadership team.
- Maintaining positive company image and positive relationships with key customers and regulators; will represent the company as appropriate in its relationships with external entities.
- Developing and maintaining a robust site quality plan
- Developing talent to provide for an engaging employee experience and succession in Quality.
- Emphasizing the critical need for timely delivery through the lens of full compliance.
- Leading all site activities in compliance with quality system regulations as required per GxP standards, and ensuring that the site operations follow all applicable laws and regulations.
- Ensuring PPI (Practical Process Improvement) is embraced across the quality organization.
- Formulating and implementing quality procedures and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
- Ensure a robust audit mechanism is established locally.
- Building rapport with workforce to promote quality and safety, ensure efficiency and develop high morale.
- Your profile:
- B.S. Degree in business or a scientific/technical field required. Advanced degree a plus.
- 1O+ years' experience in Quality Assurance, and ideally exposure in Production or Distribution.
- Previous experience in a heavily regulated manufacturing environment preferred.
- Proven ability to manage multiple priorities and projects in a cross-functional, matrixed environment
- Ability to translate business demands into an operational quality plan.
- Ability to quickly build deep connections with customers that drive trust.
- Sophisticated understanding and ability to adhere to established quality standards and regulatory compliance requirements highly preferred. Collaboration skills - Able to effectively collaborate with peers in other functions and with colleagues in other businesses or divisions
- Ability to lead, motivate and influence others. Excellent at team building, coaching and mentoring, with a passion for inspiring others at all levels of the organization.
- Experience in developing others through personalized development plans with a track record of developing future leaders.
- Embodies our Thermo Fisher values of Integrity, Involvement, Intensity and Innovation.