Director of Quality

Job Description

A leading company in the pharmaceutical industry is currently seeking a Director of Quality to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Provide technical quality support for internal and external teams and projects

2) Ensure robustness of process to meet CPPs and CQAs to achieve process reliability

3) Oversee analytical methods validation and process validation for insulin analog drug substance and product

4) Review and approve procedures, master batch records, or any other documentation to ensure the successful manufacture of the product

5) Review and approve quality system records including change requests, deviations, and CAPA as necessary

6) Provide quality input to new facility design changes as new needs are evaluated.

7) Decision-maker for validation/qualification of insulin biosimilars and escalation of issues to management with a focus on problem-solving

8) Oversee disposition of drug substance

9) Ensure manufacturing and QC adherence to company policies and procedures, regulatory licenses, industry standards and GMP regulations

10) Represent QA during site health authority inspections and business forums, including site leadership teams

11) Ensure staff training and development

12) Partner with and influence other departments and functions throughout the organization, including Operations, Site Quality, Regulatory Affairs and Technical Development and Services to implement ongoing product and process robustness to continuously improve

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the pharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in quality management

If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Director of Quality role, you must be someone who is experienced and passionate about quality management.

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience