Manager, Quality Systems, Compliance & Data Integrity

Job Description

The business site

Our site in Groningen is part of the world class Pharma Services of Thermo Fisher Scientific and we are looking for an experienced leader in a complex and highly regulated environment. Are you the leader that has a track record in bringing teams to operational excellence? You’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe! You will have a real-world impact, and you’ll be supported in achieving your career goals.

Pharma Services offers our clients a powerful platform for their drug development with technologies that are industry standard to state of the (including Single Use Technologies such as Single Use Bioreactors).

To achieve compliance, quality systems are defined, implemented, and maintained. The Quality Systems Group is responsible for developing, implementing, updating, and auditing the Quality System of Thermo Fisher Scientific Groningen, and for keeping the regulatory status of our site updated.

Emphasis of the job is on the QMS elements Quality Management; investigations and CAPA; Management of Docs, data and Data Integrity, vendor management, validation, audits and regulatory inspections.

How will you make an impact?

The Manager, Quality Systems, Compliance & Data Integrity will lead the team and be responsible for compliance with rules, regulations and guidelines following the PSG QMS Elements. This should be achieved in an effective and efficient manner to ensure competitiveness of the site. Furthermore this position will be responsible for ensuring that all deliverables for implementation of new, and re-qualification of existing GMP systems, meet the applicable regulatory policies for validation and qualification; serves to ensure that all validation activities on site, are completed in accordance with cGMP requirements (e.g. good documentation practices), adhere to the approved Standard Operating Procedures, are consistent with emerging/existing corporate & regulatory guidelines as necessary and are continuously improved through leveraging the Quality Systems architecture and execution by the organization.

The position fulfills the role of Data Integrity manager to ensure operations operates under applicable regulatory policies for documentation and data integrity/guidelines as well as striving for continuous improvement coordinate and facilitate meetings with cross-functional groups to develop, implement and maintain the Quality Systems at the required level with the purpose to maintain our licence-to operate.

Essential Functions

• Lead and guide your team through change, develop and empower the team to be successful. Drive engagement and create a climate where staff are motivated to do their best.

• Supervise staff who perform quality management reviews, quality audits, quality metrics, documentation management system, deviation and change control management systems, complaints, supplier qualification, validation oversight and/or investigations at the site.

• Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.

• Supports systems and new product introduction as a technical resource by supporting quality agreements, client questionnaires, providing technical expertise, problem solving, and strategies for problem prevention.

• Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.

• Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.

• Fulfills the role as Data Integrity manager and represents the site in global DI network.

Education

Bachelor’s degree in science or technical field preferable.

Experience

Minimum of 5 years of QA experience in the pharmaceutical industry.

• Experience in leadership role, preferable

• Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

• Knowledge in GMP’s and FDA regulations

• Strong decision making skills.

• Technical and operational knowledge in QA and Quality on the floor.

• Outstanding attention to detail and organizational skills.

• Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.

• Demonstrates ability to maintain a high degree of confidentiality.

• Requires discretion and independent judgment.

• Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.

• Highly effective verbal and written communication skills.

• Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Lead by example set the example for others to follow