Manager, Regulatory Compliance/ Operations

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Bristol Myers Squibb IrelandBristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.For more information about Bristol Myers Squibb, visit us at BMS.com/ieThe RoleBMS External Manufacturing is looking to recruit a permanent Manager, Regulatory Compliance/Operationswho will report directly to the Associate Director, Regulatory Complianceand will be responsible for all regulatory support activities within External Manufacturing.Key Duties And Responsibilities

• Working as part of a team dealing with global market registrations and providing regulatory compliance/operations guidance, and support to all External Manufacturing groups.
• Coordination of EXM quality dossier (Module 2 and 3) review process for Pharmaceutical and Biologics products at all nodes of the supply chain for new product introductions, and post approval variations including but not limited to new manufacturing facilities and process changes.
• Point of Contact for requests to source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, CoA’s, Analytical raw data) to support regulatory requests for post approval variations, renewals, and annual reports.
• Support product release by managing appropriate systems to ensure product market compliance to enable seamless release of finished product to the market.
• Review of local and global change controls, deviations, CAPA’s, technology transfer plans, and regulatory submission plans.
• Maintains strong communication and working relationships with all departments, contract manufacturing organisations, and global personnel such as CMC.
• Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR’s, quality risk management).

Qualifications, Knowledge And Skills Required

• The successful candidate will have a minimum of 3 years Quality/Compliance/Technical experience in a biopharmaceutical operations role.
• Regulatory experience and familiarity with regulatory dossier sections (Module 2 and 3) would be advantageous.

The Candidate Should Be Able To Demonstrate

• Ability to work independently and within team matrix environments.
• Ability to manage teams associated with individual aspects of responsibilities, direct people management and project management aspects.
• Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements.
• In depth knowledge of Quality Management Systems with an emphasis on change control principles and the applicability of restriction/regulatory holds in the release process for changes that require health authority approval.

What’s Important To UsEmployees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

• Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
• Innovation: We pursue disruptive and bold solutions for patients.
• Urgency: We move together with speed and quality because patients are waiting.
• Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
• Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
• Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.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, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.