Manager Quality Systems amp Compliance

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary:

The Quality Risk Management Lead will have the role of Local Process Owner for risk management processes and lead the Devens site Quality Risk Management governance forum for this critical element of the Quality Management System (QMS). The Quality Risk Management (QRM) Lead will drive risk identification, assessment, and mitigation processes ensuring a consistent approach to risk management. The QRM Lead will provide direct support and mentoring to the Devens site in order to promote understanding and adoption of risk-based approaches, build QRM capability within the business, and ensure that risk management activities comply with internal standards and health authority expectations.

Responsibilities:

Work to ensure that risk-based approaches are embedded into the relevant elements of the Quality Management System and that these approaches are aligned with BMS global policies and procedures as well as regulatory expectations

Provide subject-matter expertise and consultation to risk assessment teams at the site

Personally facilitate complex or cross-functional risk assessments

Manage the escalation and reporting of risk information to management and support the continuous improvement of BMS risk reporting processes

Develop and deliver training on QRM concepts, methods and regulatory expectations

Cultivate a network of trained QRM practitioners within the site and operating units

Promote the development of a risk-aware culture at BMS and ensure alignment of these efforts with broader Quality initiatives

Lead the Devens site Quality Risk Management governance forum

Create and maintain site risk register

Performs review and approval of site and department SOPs

Directly participates in internal audits as well as global health authority inspections

Commitment to act in accordance with BMS’ values: Integrity, Innovation, Urgency, Passion, Accountability, and Inclusion

Knowledge and Skills:

Required:

Bachelor’s or graduate degree in a scientific or engineering discipline, or its equivalent is required

A minimum of 10 years of relevant experience including experience working in within or supporting a GxP-regulated function

Expertise in ICHQ9 and Quality Risk Management Program Implementation is required

Strong knowledge and proven experience in applying risk management tools and methods (e.g., FMEA, PHA, HAACP, Risk Ranking and Filtering)

A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make BMS a model for the industry relevant to QRM

Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMEA, Health Canada, etc.

Demonstrated leadership, communication, and motivation skills

Strong interpersonal skills and the ability to apply these within a global, matrix organization (i.e. relationship building, listening, negotiation, and conflict management).

Excellent communication skills. Demonstrated ability to write clearly and concisely.

Ability to balance multiple assignments in a fast-paced environment

Ability to lead and direct change via influence rather than direct control

Ability to drive collaborations across functions to accomplish objectives

Preferred:

Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable

History of active participation within pharmaceutical industry organizations (e.g., PDA, ISPE) in the area of Quality Systems and/or QRM

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com