We have been retained by our client, a top calibre and well established multinational pharmaceutical company to recruit a QA Operations Manager.
The QA Operations Manager is responsible for all aspects of Quality Assurance across the site including existing commercial operations, technical transfers and new technology platforms. This role has a primary role in assuring that products manufactured at the site are done so in accordance with cGMPs and pertinent corporate and regulatory requirements, in addition to ensuring support for local and global batch release.
The QA Operations Manager, who will be a member of the Extended Leadership Team, will also have much corporate exposure in a key role where confidence building with customers, regulatory authorities and associate companies is a critical factor. It is expected that the person who succeeds in this role will have a strong prospect of progressing into a more senior position within the organisation.
- Provide quality expertise and oversight of cGMP activities across the site.
- Ensure operations and support departments are in compliance with cGMP.
- Manage QA team through QA Managers to provide quality and compliance support for the site.
- Ensure Qualified Person support for site and global batch release.
- Ensure preparation and support for regulatory and external inspections.
- Ensure effective stakeholder management for corporate support departments, bulk drug substance manufacturing sites and associated sister sites.
- Be an effective and engaged member of the broader Quality Leadership and Extended Leadership teams to manage the day to day business ensuring supply to patients and protection of our right to manufacture medicines.
- Strong leadership and personnel development skills.
Skills & Knowledge
- Operational experience of quality systems in a dynamic manufacturing environment.
- Ability to lead/provide strong input into technical investigations.
- Understanding of Quality Management Systems and cGMP for US and EU.
- Able to manage projects to plan/budget.
- Effective facilitator with strong leadership skills and team development skills.
- Strong communication skills at organisation, team and individual levels.
We require candidates with a degree in Science or related area (Chemistry, Biochemistry, Biotechnology, Microbiology or Pharmacy preferred) with Post-graduate studies as appropriate to augment primary degree – MBA advantageous. Qualified Person status is desirable but not essential.
He/She will have extensive experience working in the pharmaceutical sector including sterile manufacturing coupled with several years’ experience in management of QA. Candidates will have Project Management and Quality Systems Management Experience as well as extensive experience hosting of Regulatory (FDA/HPRA/Worldwide) and Corporate Inspections.
This is an excellent opportunity to participate in and contribute to the continued success of an established multinational company. An attractive salary and benefits package will be offered. Please send full career details, quoting position no. G18020 to GMB. Applications may be sent by email: email@example.com, post to GMB, 4 Fitzwilliam Terrace, Strand Road, Bray, Co. Wicklow, Ireland or telephone Peter O’Leary on +353 1 2867692 for an initial discussion. Web: www.gmb.ie No information will be disclosed to our client without prior permission from applicants.