Associate Director, Qp Operations

7 maanden geleden

Utrecht, Nederland Bristol-Myers Squibb Voltijd

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Bristol Myers Squibb Ireland**

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.

**The Role**

BMS Biologics is seeking to recruit an Associate Director to lead a QP team responsible for Finished Drug Product (FDP) certification of biologics for the EU/EEA and ROW markets.

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.

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.

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs

**Key Duties and 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.
- 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 train

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