Senior Manager, GDP Operations EMEA/ APAC

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 Ireland

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients’ lives through science.

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Many of the global business services, including the European Treasury Centre, Market Supply Operations and Commercial Operations have a presence in Ireland.

Ireland is also 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.

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.

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

Bristol Myers Squibb is looking to recruit a permanent Senior Manager, GDP Operations EMEA/ APAC.

The Senior Manager, GDP Operations EMEA/ APAC is responsible for supporting the maintenance of the Quality Management System for EMEA/APAC. These activities include change control, non-conformance investigation, supporting internal/ corporate and health authority inspections, supply chain projects, compilation of metrics and document management. This role will interface with In-Market Quality and Global Supply Chain Compliance colleagues.

Key Duties And Responsibilities

• Prepare, update, and/or approve procedures in accordance with GMP/ GDP and company requirements
• Manage all documents in accordance with records management procedures and data integrity requirements
• Serve as the Local Process Owner in the execution of QMS activities, compliance initiatives, best practices, and industry standards per implementation strategy
• Monitor deviations, internal and external change controls and CAPAs, standalone actions to ensure progression and timely closure.
• Develop responses to internal audits and ensure appropriate implementation of corrective actions as required
• Support and participate in local initiatives or projects to increase compliance and reduce costs/ non-conformance.
• To review executed forms (destruction, redeployment, etc) and ensure GDP requirements are met .
• Ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain.
• Management of complaints, ensuring they are dealt with effectively
• To escalate any complaints, reported defects, reported falsified medicinal product
• To lead technical or risk assessment exercises where needed including contracted activities which may impact on GDP.
• To execute ad-hoc reviews of processes and procedures and provide support in collaborating with Compliance Excellence on executing the self-inspections per defined intervals) and implement corrective actions as necessary.
  

Qualifications, Knowledge And Skills Required

• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Innovative
• Excellent communication skills both written and verbal
• Attention to detail
• Results and performance driven
• Adaptable and flexible
• High customer orientation, excellent interpersonal, communication and teamwork skills
• Ability to build trustful relationships, engage and influence stakeholders at all levels, including market and GPS leadership
• Excellent analytical, organizational, and problem-solving skills
• Bachelor’s Degree in a Scientific/ Technical discipline required
• Extensive experience in a Quality or compliance role within the Pharmaceutical industry, most specifically in relation GDP.
• Certified in Lean Six Sigma
• Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use Up to date knowledge of relevant pharmaceutical legislation and GDP.
• Ability to apply GDP regulations and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations as they apply to quality, including those of HPRA, EMEA, FDA and other authorities
  

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
  

BMSBL

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.