Director Quality Systems and Compliance/Integration

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.

Principal Objective of the Position:


Regulatory compliance & quality systems activities and quality programs across Product Development to ensure adherence to BMS standards and global health authorities requirements.

Collaboratively with the Product Development leadership to lead and drive compliance at the site, through review and approval of procedures, internal audits, training and ensuring that robust quality systems are in place.

Leads integration of Quality Systems across both legacy companies, providing strategic direction across multiple stakeholder groups.


Key Responsibilities and Major Duties:


Leads a team to oversee Quality systems and compliance activities across product development

Collects and communicates Quality metrics across PD, drives strategic change in quality systems performance monitoring

Manages and co-ordinates PD quality Council and ensures linkages to Tier 1 and Tier 3 Councils

Manages the Clinical Product Complaints programme

Hosts internal and external audits; Approves corrective actions related to self-inspections and internal/external audits

Leads global regulatory agency inspections and manages all commitments/CAPAs until completion, ensuring 100% compliance with due dates

Manages the Quality Agreement program with suppliers, alliance partners and contract manufacturing organizations (CMOs) to ensure that applicable regulatory and company requirements are met;

Oversees the quality risk management (QRM) program and Quality Risk Register for the site

Leads fact finding investigations into significant events/issues with potential impact on product quality and clinical supply continuity

Oversees the development, management and continuous improvement of procedural documents to ensure a robust, compliant, and efficient Quality System Framework

Ensure compliance to applicable Quality Policies, Directives, SOPs, FDA and EU guidances, rulings and current good manufacturing (cGMP) practice.

Ensures that that procedures are properly followed and adequate for their use

Serves as a valued source of cGMP information to internal and external stakeholders

Provides GMP training for Quality Operations and the Product Development community

Ensures that an adequate documentation and records management system is in place

Lead continuous improvement initiatives and drives simplification of processes

Ensures that all Quality personnel have adequate training, education and experience to perform their job function effectively and updates training curricula.

Adherence to BMS core behaviors


Key Competencies – knowledge, skills, abilities, other:


Strategic thinker with enterprise mindset

Ability to drive change through complexity and manage stakeholders

Demonstrated leadership, interpersonal, communication and motivation skills

Continuous Improvement mindset

Interprets regulations and maintains an awareness of industry trends on compliance issues.


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

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