Do you have previous experience leading all Quality operations?
Are you looking for an opportunity to work closely with both Quality Assurance (QA) and Quality Control (QC) teams at a growing site?
Are you located in Poland, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a biologics organisation specialising in producing generic drugs and medicines. Operating worldwide, they are committed to improving and saving lives.
Our client is seeking a leader to provide management and quality oversight and leadership for the site.
Discover more about our Site Director of Quality opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Site Director of Quality, you will be measured against the following objectives:
1) Ensuring operational coordination of Quality management.
2) Ensuring site inspection readiness to obtain the GMP certificate.
3) Facilitating change management and pushing Quality up the agenda.
What you will do:
As the Site Director of Quality, your duties and responsibilities will include:
- Preparing and reviewing required GMP documents, assisting in inspection preparation to obtain the GMP certificate.
- Supervising the preparation of areas for a variety of inspections and audits.
- Conducting and/or participating in internal and external audits.
- Evaluating, developing, and approving Quality Management System documentation.
- Developing, updating, and implementing the system GMP documents, policies and standards for QA and QC.
- Ensuring the fulfilment of all requirements regarding all QM systems and Change Control, deviation and risk management, qualification and validation, and self-inspections etc.
- Coordinating and supervising that QC is conducted in accordance with legal requirements.
- Ensuring that a high quality of products is achieved through qualification and validation based upon quality risk analysis, product quality assessments and ongoing verification.
- Being responsible for QA support for clinical trials (GCP), and Good Pharmacovigilance Practice as aspects of the product life cycle.
What you will bring:
These are the skills and experience you will need to succeed as the Site Director of Quality:
- Demonstratable leadership skills and proven experience motivating team members.
- Confident decision-maker and ability to make practical, compliant decisions.
- Persistence and determination to overcome setbacks and drive business performance.
- Self-motivated and accountable individual prepared to fix any issues that arise.
- Ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.
- Previous experience facilitating change management in Quality.
- Bachelor’s degree in Science related discipline or equivalent.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Health insurance
- Short-term bonus
- Long-term bonus
Got what it takes?
To apply for the Site Director of Quality, click the ‘Apply’ button below or contact the Executive Search Consultant – Peter Vedde – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.