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Our international client is a life science tools provider, who enables customer development and commercialisation of life-saving regenerative medicine cellular therapies. They develop, manufacture and market hypothermic storage and freezing solutions for cells, tissues, and organs. Their platform of solutions is highly valued in the regenerative medicine, biobanking, and drug discovery markets.
They are looking for an Associate Quality Director to join their dynamic, high-energy corporate culture.
In this role, you will be responsible for building and maintaining a Quality Management System at the EU facility for transport and storage of pharmaceutical and biological products for human & medical use, in accordance with the EU regulations. Duties will include managing quality agreements with manufacturers and service providers, reporting of quality defects, demonstration of GDP (Good Distribution Practice) knowledge through preparation for GDP inspection. The Associate Quality Director will be tasked with engaging and driving quality management and inspection readiness within the organisation.
Job Profile for Associate Quality Director
Responsibilities will include but not be limited to:
- Create, manage & continually improve the development and implementation of quality system procedures and support documentation through the business operations
- Assess compliance to industry guidance & standards, and leads site to achieve compliance to those standards
- Ensure Quality Management System is compliant with applicable federal regulations and select quality standards deemed strategic to the service offering
- Support all site leadership to maintain compliance throughout the site operation
- Represent the company in a professional manner and uphold the highest interactions with other employees, customers, suppliers and third parties
- Communicate Quality System status to Quality Management and Leadership
- Ensures all service offerings are delivered according to internal specifications and procedures
- Assign, review, and approve Corrective and Preventive Actions
- Respond to customer feedback and investigate complaints
- Support customer requests for information in their regulatory/quality filings
- Ensure qualification of all key suppliers and oversee validations, qualifications and verifications
- Own the internal audit and supplier audit program, ensuring only suppliers appropriate for use are qualified
- Host on-site customer audits, conduct supplier and internal department audits with Quality Leadership
- Ensure change is implemented in a controlled fashion
- Ensure new products are designed and developed in accordance to regulatory and standards requirements
- Oversee risk management program
- Review and approve Investigations/Deviations/Scars
- Review Quality Agreements
- Create, review, and approve SOP’s
Candidate Profile for Associate Quality Director
- Must be fluent in English, both written and spoken
- A bachelor degree is required (preferably in life science) or equivalent experience. A master’s or other advanced degree is preferred
- 7-10 years experience in a regulated environment in roles of a related discipline (e.g. Quality Assurance, Regulatory, Operations, Project Management), with 5-7 years supervisory experience or equivalent experience
- Proven ability to communicate with management and business leaders in a global operations setting
- Proven ability to understand, analyse and communicate the impact of global regulatory issues affecting distribution/storage of API, biological products.
- Has experience in quality improvement methodologies such as FMEA, Six Sigma or other similar BOK
- Has demonstrated ability to lead and influence/guide at all levels
- Experience with the Quality Program for biorepository operations
- Experience writing validation studies and interpreting results
- Experience with basic statistical analyses
- Ability to creatively collaborate with team members
- Is proficient in Microsoft Office programs
- Has the ability to effectively manage multiple priorities with challenging timelines
- Has high integrity
- Is able to use sound judgement and reasoning to solve daily tactical issues
- Must have a comprehensive working knowledge of local, state, federal and international cGMP regulations; FDA/EU/ICH guidelines; validation standards, QMS and quality risk management principles
- Develop and Maintain QMS and Regulatory Registrations
- Must have an understanding of ISO 9001 and ISO 20387 applicable to Biorepository storage functions
- Must have regulatory experience with the following
- GDP for API – Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
- GDP for Human Medicinal Products -Good Distribution Practice of medicinal products for human use (2013/C 343/01) ICHQ9 and ICHQ7
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