Description:
The Associate Director will work independently on behalf of the QP operations organisation to provide conceptual and practical expertise in QP requirements and ways of working. They will use best practices and knowledge of the regulatory landscape to improve products/services or processes across the business. Typically, work will involve resolution of complex problems or problems where precedent may not exist.
The individual will represent the QP team on cross- functional projects and support in the implementation, organizing, managing, and execution of the Quality Management System of the relevant entity. Thereby, ensuring product quality and compliance of relevant activities with all regulatory and corporate requirements within EU/EEA and ROW Markets, as applicable.
Where required, the Associate Director will manage Senior Manager/ Qualified persons and other quality professionals providing support and guidance to colleagues, as needed.
The Qualified Person is invested with the authority to make decisions with regards to produc t quality, safety, purity, and efficacy independent of other business interests.
Key Responsibilities
- Certification of batches of finished product to EU/EEA and ROW markets which have been manufactured and checked in accordance with its Marketing Authorisation, the principles and guidelines of GMP as laid down in Directive 2003/94/EC and other relevant legal requirements.
- Perform release duties on behalf of registered site of release for products not listed on the MIA under the remit of the QP team, as needed.
- Act as QP primary contact for a product/brand related queries, as required.
- Represent the relevant Qualified Persons team in a cross-functional capacity taking the lead from a QP perspective on company- wide projects and initiatives.
- Provide guidance to the Quality Operations teams to support batch certification activities.
- Actively support the BMS Fact Finding Investigation Teams (FIT), Fact Finding review Meetings (FIRM) and Product Review Committee (PRC) processes for quality events and investigations.
- Collaboration with launch excellence and other functional areas to support new product introductions and new market launches.
- Act as an SME in regulatory and corporate audits.
- Participation in the product recall process and/or Health Authority notification processes.
- Continually maintain familiarity with the manufactured and tested requirements specified in the Marketing Authorisation, national legislation or cGMPs for all products under their remit as per the MIA.
- As required, manage a team of Senior Manager, Qualified Persons and /or other Quality professionals.
- Provide quality and compliance guidance on critical and major quality matters.
- Develop and maintain QP oversight procedures/ processes for both internal and CMO sites to continually support the QP function.
- Undergo continuous professional development including self- study, site visits, internal and external training courses to m aintain an up-to-date knowledge of pharmaceutical legislation and industry practice.
- Core competencies include strong decision making, leadership, communication, coaching, teamwork and problem-solving skills.
Qualifications & Experience
- Educated to a degree level in science, engineering or related discipline with a minimum of 10 years' experience in the biopharmaceutical/pharmaceutical industry.
- Eligible to act as Qualified Person in accordance with the EU Guide to Good Manufacturing Practice as defined in article 51 of Directive 2001/83/EC with a minimum of 2 years' experience as an acting QP named on a Manufacturer's Authorisation.
- Experience in manufacture of biological products and/or aseptic manufacturing would be beneficial.
- People management experience would be an advantage.