Associate Director, Quality Systems and Compliance

Recruiter
Bristol-Myers Squibb
Employment Type
Permanent
Salary
Not disclosed
Bristol-Myers Squibb logo

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 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.  

For more information about Bristol Myers Squibb, visit /ie

The Role

BMS Cruiserath Biologics is seeking to recruit a permanent Associate Director Quality Systems and Compliance.  The role is responsible for providing the strategic direction, oversight and management of all Quality Systems, Compliance and Supplier Quality related activities at Cruiserath Biologics as defined by the Site Head of Quality. 

Key Duties and Responsibilities:

  • Development and implementation of a robust quality system aligned with BMS policies and procedures to support commercial bulk drug substance manufacture and release, to support the Global Biologics Laboratory and batch certification activities.
  • Ensuring quality oversight of site compliance and quality systems activities including Quality Risk management, internal auditing, inspection management, records management, non-conformances, CAPAs, change control, APQR generation and complaints management.
  • Hiring and directing resources to implement and manage the site’s quality & compliance system and drive continuous improvement to ensure continuous quality of product to patient. 
  • Facilitating the development of GMP Training Curricula for both quality and non-quality functions.
  • Directing Supplier Quality activities at site including but not limited to Quality Agreements, Materials Qualification, supplier auditing program to ensure that raw materials suppliers, services suppliers and equipment vendors meet applicable regulatory and company requirements.
  • Release of raw materials and consumables
  • Has oversight of and leads the Site Inspection Readiness Program by collaborating with Site stakeholders to conduct readiness assessments against the relevant HA requirements, benchmarking with prior network experience, and maintaining relevant training
  • Primary contact with all regulatory authorities including leading global regulatory agency inspections and managing all responses, CAPAs and lessons learned.
  • Ensures all licenses held by the site are appropriately managed, variations submitted as required and Site Master File (SMF) is maintained.
  • Establishing and managing the site Quality Council by sponsoring and driving Quality initiatives that directly impact the Site operations
  • Supports the notification to management process for the Cruiserath Site ensuring all HA defect reports (QDNs, BPDRs etc) are submitted as required.
  • Maintain a sound knowledge of European & US and rest of world regulatory requirements to provide advice and expertise on-site and cross-training to colleagues on regulatory matters
  • Represents Cruiserath site as the Quality representative on network compliance and Quality Systems initiatives and providing compliance leadership, guidance and problem solving skills.
  • Participates in the product recall and health authority notification process in accordance with BMS procedures
  • Promotion of best practices and a culture of continuous Quality Improvement in all Quality Management Systems on site.

Qualifications, Knowledge and Skills Required:

  • A degree in science, engineering or related discipline is essential along with extensive experience in the biopharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority Agency. 
  • Demonstrated effectiveness in roles directly related to quality compliance of commercial biologics in a FDA and EMA regulated environment.
  • Experience establishing, managing and improving commercial Quality Systems is required.
  • Knowledge of biotech analytical testing, in addition to bulk and finished product manufacturing is highly desirable
  • Experience in building and growing an organization, and ability to lead and motivate people.
  • Experience with direct FDA, EMA, and Global HA interactions including face-to-face interactions and/or regulatory filings.
  • Demonstrated leadership skills and outstanding interpersonal, communication and motivation skills.
  • Ability to embrace collaboration with partners, customers, and team members, operate with integrity, as well as seek and participate in the continuous improvement of systems and culture.
  • Ability to build relationships cross functionally and influence internally/externally as appropriate.

What’s important to us

Employees 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.