Provide strategic leadership to oversee the implementation and continuous improvement of the R&D Quality Risk Management framework, ensuring effective roll-up and reporting of risks and insights to relevant governance forums.
Define and lead the R&D Quality Excellence and Governance strategy aligned with regulatory expectations, industry standards, and enterprise objectives.
Ensure alignment of Quality Strategy with ICH E6(R3), ICH E8(R1), Q9, BMS Quality Plan and applicable global regulations.
Lead the development and oversight of R&D Quality performance metrics to ensure effective consolidation and communication to Global Quality, Drug Development, Global Product Supply and Research, as applicable, in partnership with teams across RDQ.
Partner with Corporate Quality (CQ) and Global Quality (GQ) and maintain a RDQ quality governance framework, including councils, committees, and escalation pathways.
Monitor and report quality performance metrics, RDQ compliance dashboards and risk indicators to senior leadership and enterprise governance bodies.
Serve as a primary liaison for GQ and Drug Development to provide executive oversight of the R&D Quality Management System (QMS), ensuring scalability, consistency, and compliance with the BMS Quality Plan.
Champion compliance with key ICH guidelines (e.g. E6, E8, E9, Q9) and other relevant regulatory requirements.
Drives Quality Risk Management solutions for RDQ in collaboration with RDQLT, GQ and Drug Development.
Lead and Support the GCP serious non-compliance management process, including management of Serious Breaches, leading investigations and development of CAPA plan.
Collaborate with Global Quality, Strategy and Business Excellence, to set goals for RDQ that are specific, measurable, achievable, relevant, and aligned to the enterprise strategies, and time bounded.
Create a comprehensive plan that outlines the scope, timeline, resources, and key milestones for strategic initiatives taking into consideration potential risk and mitigations.

Requirements

B.S. and/or M.S. in engineering, scientific or related field.
Subject matter expert in Drug Development related regulations, standards, best practices.
PMP and/or Six Sigma / Lean certifications are preferred.
Minimum 10+ years in biopharmaceutical/life-sciences industries is preferred.
Proven experience in Quality Risk Management, Operating Excellence, Project Management, and leading operations or continuous improvement teams.
Leadership experience and effective communication with stakeholders at all levels, along with a keen attention to detail.
Exceptional strategic thinking abilities, adept at managing complex systems, navigating organizational politics, fostering innovation, and skilled in negotiation and management.
Possesses a strategic perspective, leading with vision and values, exhibiting global acumen, and displaying a strong leadership disposition.
Strong customer focus, interpersonal and organizational skills, with a collaborative and teamwork-oriented mindset.
Proven ability to manage multiple tasks in a fast-paced environment.
Demonstrated competencies in influencing, negotiating, relationship management, and a continuous improvement mindset.
Budget management experience, possesses an enterprise mindset, making decisions and sharing resources for the greater benefit.
Change agility, with the ability to navigate ambiguity, take calculated risks, and lead others through change.
Strong organizational and problem-solving abilities, with a sense of urgency and the capacity to manage priorities and timelines effectively.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Risk ManagementProject ManagementContinuous ImprovementQuality Management System (QMS)Performance MetricsRegulatory ComplianceDrug Development RegulationsCAPA (Corrective and Preventive Action)GCP (Good Clinical Practice)Strategic Planning

Soft Skills

LeadershipEffective CommunicationStrategic ThinkingInterpersonal SkillsOrganizational SkillsNegotiationCollaborationAttention to DetailChange AgilityProblem-Solving

Certifications

PMP (Project Management Professional)Six SigmaLean