What will you do?
QA Operations Manager will lead the QA Operations department and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
Key responsibilities :
The QA Operations Manager reports to the Site Quality Head and manages a team of 4 direct reports (total team of c. 20)
Assure the proper cGMP compliance status of all the activities conducted at site. Assure appropriate oversight at shop floor level
Assure the appropriate regulatory and cGMP status of all those documents necessary for the release of the batches produced at site
Set and maintain a proper quality plan in order to assure the compliance with national and international regulation
Manage deviation investigation and relevant CAPA identification and execution plan
Meaningful experience working in a pharmaceutical Quality department on a sterile site.
Substantial Quality Assurance experience and hands-on’ knowledge of all Quality Systems required for a sterile manufacturing facility.
Understanding of the principles of sterile manufacturing.
Understanding of Operational Excellence principles / Lean manufacturing
Knowledge, Skills, Abilities
This position requires deep understanding and confirmed application of cGMP regulations and international guidelines in a sterile production setting.
This knowledge needs to be combined with clear decision-making, pragmatism aligned with quality risk management principles to demonstrate release of product appropriate for commercial use.
Demonstrated ability to make sound decisions regarding evaluation of GMP compliance, and
of developing and influencing business strategy is desirable leadership abilities in the management of QA oversight
Eligible to act as a Qualified Person’ as defined in 2001 / 83 / EC and 2001 / 82 / EC (as amended), is preferable but not essential
Solid understanding of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210 / 211 and other relevant regulations
Confidence in making decisions for the group. Holds self and others accountable in achieving goals
A proven track record of developing and leading a high performance team
Strong leadership skills with good collaboration, communication and problem solving skills
Excellent written and verbal communication skills to internal and external partners
Wants to learn and have a natural curiosity to understand systems and processes
Ability to work in a fast paced, matrix environment is important
Capable of working to deadlines and prioritize multiple tasks
Flexibility to meet changing needs and priorities of the business
Science degree in Chemistry, Pharmacy or Microbiology