Senior Manager, QA Qualified Person

at  BristolMyers Squibb

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 recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Qualification, Knowledge and Skills

• MSc (or equivalent) in a technical or scientific discipline which and meets the EU Qualified Person educational requirements as described in Article 49 2001/83/EC in addition to any national requirements.
• Eligible to act as Qualified Person within EC/EEA.
• Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 5 years experience), including audit, batch record review, change control, complaint handling and investigations experience.
• Must have experience and good knowledge of a variety of dosage forms ideally including solids, sterile and biological products.
• Must have proven strategic thinking and contingency planning skills.
• Must have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach.
• Effective planning skills and recruitment skills to identify strong performers, hire adequate members of staff and establish a high performance organization; ability to anticipate resource needs and help establish priorities.
• Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach.
• Must have excellent organizational, project management and problem solving skills.
• Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly).
• Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
• Must have computer proficiency.
• Must have superior attention to detail

The primary role will be supporting in the implementation, organizing, managing, and execution of the Quality Assurance function and Quality Management System of Celgene Distribution BV which will ensure product quality and compliance of relevant manufacturing and distribution activities with all regulatory and corporate requirements for BMS Products within EU/EEA and Rest of World Markets as applicable. This position also acts as a Qualified Person as per requirements of Celgene Distribution BV license(s). Executes Qualified Person duties and responsibilities in accordance with Article 51 of Directive 2001/83/EC and Professional Code of Conduct. The Qualified Person is invested with the authority to make decisions with regards to product quality, safety, purity, and efficacy independent of other business interests. Products are for commercial and named patient supply use only.

Responsibilities

• As required, act as Qualified Person as per requirements of Celgene Distribution BV and Cruiserath Ireland licenses and execute functions in accordance with Professional Code of Conduct.
• Certification of batches of finished product to be released to the EU/EEA and ROW markets which have been manufactured and checked in accordance with its marketing authorization, the principles and guidelines of GMP as laid down in Directive 2003/94/EC and other relevant legal requirements.
• Familiarization with the individual product regulatory dossiers.
• Coordination of the QA team to support batch certification activities.
• Oversight of compliance and quality activities including Quality Risk Management, internal and supplier auditing, inspection management, records management, and change control.
• Collaboration with QC and other functional areas to support new product introductions.
• Approval of change controls, significant deviations, customer complaints and annual product quality reviews as required.
• Ensure quality agreements are in place to support the batch certification process.
• Act as an SME in regulatory and corporate audits.
• Participation in the site self-inspection program by conducting audits of site functions.
• Participate in GMP- or GDP-related health authority inspections or internal corporate audits at Celgene Distribution BV.
• Participation in the product recall process and BOH notification process.
• Undergo continuous professional development including self study, site visits, internal and external training courses and participation in corporate and regulatory inspections.
• Ensure access to the audits reports of sites involved in the manufacture and the testing of medicinal products being certified.
• Interact with executive level employees at third party contractors.
• Interact with Corporate and International functions as required by the tasks and responsibilities.

Qualification, Knowledge and Skills

• MSc (or equivalent) in a technical or scientific discipline which and meets the EU Qualified Person educational requirements as described in Article 49 2001/83/EC in addition to any national requirements.
• Eligible to act as Qualified Person within EC/EEA.
• Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 5 years experience), including audit, batch record review, change control, complaint handling and investigations experience.
• Must have experience and good knowledge of a variety of dosage forms ideally including solids, sterile and biological products.
• Must have proven strategic thinking and contingency planning skills.
• Must have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach.
• Effective planning skills and recruitment skills to identify strong performers, hire adequate members of staff and establish a high performance organization; ability to anticipate resource needs and help establish priorities.
• Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach.
• Must have excellent organizational, project management and problem solving skills.
• Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly).
• Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
• Must have computer proficiency.
• Must have superior attention to detail.

Why you should apply

• You will help patients in their fight against serious diseases.
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym.