Director, Quality Engineering
DIRECTOR, QUALITY ENGINEERING
Location: Amsterdam, Netherlands
Salary: Negotiable dependent on experience, excellent benefits and relocation package available if required.
Our client is a dynamic Biopharmaceutical business undergoing a period of significant growth in view of the development of their offering within the European region. This will be boosted by the opening of a brand new manufacturing site In the Amsterdam area, and they are therefore seeking to appoint a highly experienced Quality Assurance Professional into this senior, managerial role with a view to building a team of subject matter experts within Quality assurance and Computer System Validation. In view of the small scale of the operation at present, this represents an excellent opportunity for a talented, ambitious, hands-on individual to have a major impact in the shape and design of this function as the business grows.
As the Director, Quality Engineering, responsibilities will include (but not be limited to):
The development of validation master plans based on cGMP/ISPE guidance for all processes and methods related to the lead product and follow on products.
The further development, implementation and continual improvement the qualification and validation program requirements
Overseeing computer system validation for the business in Europe.
Building and effective management of a team of Quality Engineering subject matter experts.
Management of the change control process for validated computerized systems.
Ensuring alignment of automation system qualification with the company CSV procedures.
Driving computer system compliance aspects across the company EU project portfolio.
Partnering with the corporate Quality engineering department around automation strategies.
Supporting regulatory inspections and audits.
Management of the risk assessment process for computer system validation.
Providing technical response and expertise during audit and inspections for areas under responsibility.
Planning, scheduling and involvement with project management of technical projects with cross-functional teams.
Reviewing technical/investigation reports as appropriate.
Reviewing and approving proposed changes to systems and procedures, as appropriate.
The tracking, review and reporting of metric information for use in continuous improvement of areas of responsibility.
The successful candidate will possess:
A number of years of Computer System Validation and Equipment Qualification experience in a Life Sciences GMP environment (Pharmaceutical or Medical Devices).
Solid knowledge of quality systems and regulatory requirements (EU GMPs, ICH 8, ICH 9, ICH 10).
Experience with internal and external audit principals.
Strong knowledge of change control practices/strategies.
Minimum 5 years of people and process management experience.
Strong written and verbal communication skills.
Bachelors degree in technical discipline (Computer Science/Engineering or similar).
Bilingual/Fluent in English.
As mentioned this opportunity represents an excellent career move for the right candidate to join a business at an exciting point in their development, and to have their say in the development of a talented, highly performing Quality function.
To apply for this position, please call Jim Maddison at Clinical Professionals on +44 (0) 207 822 1710 or send an updated version of your CV via email to firstname.lastname@example.org
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