- BBBH794562 Sep 30, 2021 Competitive
A gem of an opportunity for a Senior Quality manager looking for their next opportunity within Product Quality. This is an excellent organisation and team to join
This is a rare opportunity to join a global pharmaceutical leader as a Senior Manager of Product Quality
As part of the Quality leadership team, this individual will be responsible for evaluating and ensuring quality of product sourced under the business' brand/
The postholder will need to ensure that appropriate systems and processes are in place to comply with current regulations and reduce risk across the business' extensive product portfolio.
In this role you will be responsible for managing and developing the product quality team and will provide quality leadership for their group and within the wider team.
- Lead a product quality programme to provide oversight.
- Provide direction and support to quality team and manufacturers
- Ensure processes are in place to support the Private Labels to maintain compliance.
- Liaise and build relationships with manufacturers, and stakeholders, to ensure product quality issues are investigated in a timely manner and are documented appropriately
- Ensure product complaints are investigated and closed and escalation of serious complaints to senior management and suppliers
- Ensure contact manufactures maintain compliance with quality agreement
- Liaise with the Supplier Quality Group, to focus on key quality areas of outsourced activities during supplier audits
- Liaise with suppliers on product risks such as Field alerts and potential market actions
- Ensure timely action for Quarantine and activities which may impact DSCSA compliance
- Ensure systems are in place for the monitoring of outsourced laboratory and stability testing for the relevant products.
- Ensure internal Deviation and CAPA's are progressed and closed in a timely manner
- Keep Quality Management and team updated on issues which impact the business
- Liaise with internal and external customers, provide data and assistance to ensure Private label activities run smoothly
- Empower, coach, develop personnel and oversee team activities
- Create and maintain a culture of continuous improvement throughout the team and organisation
- Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge, and experience as required and cross training as required
Education & Experience:
- Educated to degree level or higher, ideally B.Sc. or post graduate studies in Chemistry, Microbiology, Chemical Engineering; other related scientific disciplines may be considered.
- 7+ years experience in finished dose pharmaceutical manufacturing and/or medical devices organisation, preferrable in a multinational.
- At least 2 years management experience
- Strong familiarity with US and relevant International regulations.
- The post holder will have technical manufacturing, quality or laboratory experience.
- Solid understanding and knowledge of cGMP and the regulatory framework for the manufacture and supply of finished dose pharmaceutical products
- Thorough knowledge of pharmaceutical manufacturing, testing and batch release processes
- Sound technical knowledge of multiple dosage forms or dosage types
- Proven record in analytical decision making on complex analytical issues
- Strong soft skills with ability to communicate at all levels within the organisation and drive results
- Ability to work effectively with others inside and outside their team to accomplish goals in a timely manner
- Excellent team and time management skills
If you are interested in this opportunity, or if you would like to find out more, reach out to Kellie O'Donovan today on 021 2300 300 or firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Principal Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300