Bristol Myers Squibb Company

Associate Director, PV & Lifecycle Management Quality (US, LATAM, Canada)

Location
Princeton, NJ, United States
Posted
Aug 31, 2020
Ref
R1526033
Discipline
Quality, Quality Control
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Job Title

Senior Manager / Associate Director, PV & Lifecycle Management Quality (US, LATAM, Canada)

Division

Global Product Development & Supply (GPS) - Global Quality, Research and Development Quality

Functional Area Description

Global Quality, Research and Development Quality (RDQ) manages quality related activities across GxP in support of the R&D, GDD, GPS and GMA/Commercial organizations.

The RDQ - PV and Lifecycle Management Quality function provides independent quality oversight on the clinical safety/PV, RA and MA quality management systems applied during the lifecycle of products, managed by global internal and external stakeholders.

In addition to providing PV, RA, MA quality SME consultancy, the primary focus of the group are to:

- Continuously monitor the health of the QMS and initiate actions where needed;

- Watch Health Authority commitments, submission strategies and the planning/execution thereof;

- Manage/support PV inspections;

- Execute risk-based PV audits.

Position Summary / Objective

The Associate Director will work in the RDQ, PV and Lifecycle Management Quality group and reports to the Senior Director, PV and Lifecycle Management Quality in RDQ. Primary responsibilities are to oversee the quality management system relating to Clinical Safety/ Pharmacovigilance, Regulatory and Medical Affairs activities applicable to the US, Lat Am and Canada, in addition to acting as an expert in clinical safety/pharmacovigilance related areas and providing inspection and audit support.

Position Responsibilities
  • Ensure oversight on the Clinical Safety/PV Quality Management System applicable to the US, Latin America and Canada region, in consideration of global and regional PV legislation; and business strategies;
  • Perform independent risk assessments and stakeholder interviews to inform the annual audit program. Review the program on a quarterly basis and document deviations;
  • Perform PV, RA and MA audits, in accordance with the audit strategy and annual audit program, including audits of critical processes, affiliates, service providers/vendors and licensing partners to assess regulatory compliance;
  • Participate in qualification audits of potential new vendors/partners;
  • Approve Root Cause Analysis, CAPA and effectiveness measures in response to audit findings within procedural timeframes. Pro-actively engage with finding owners to ensure sufficient guidance is provided to ensure timely agreement on CAPA;
  • Participate in the preparation, hosting and follow-up of regulatory authority inspections related to clinical safety and pharmacovigilance activities at central sites, affiliates and partners/vendors, as assigned;
  • Maintain an in-depth knowledge of regulations as they apply throughout a product's life-cycle, with primary focus on Clinical Safety/PV, and act as an expert resource/trainer;
  • Act as an advisor and back-up to the Senior Director, PV and Lifecycle Management Quality;
  • Participate in GPS and/or BMS company process- and improvement initiatives, as assigned;
  • Lead or co-lead compliance Investigations, as assigned;
  • Directly supervise audit staff, including responsibility for providing ongoing guidance, development and performance assessment and/or manage a local audit function as assigned;
  • Provide mentoring for new staff, as assigned;
  • Represent the RDQ-PV and Lifecycle Management Quality position during internal and external meetings, as required.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree Requirements

University Graduate, Life Sciences degree preferred.

Experience Requirements

Demonstrated expertise and specific technical knowledge of clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs activities pertaining to assigned region as evidenced by at least 8 years in the pharmaceutical industry or equivalent.

Minimum of 5 years of technical auditing and/or related experience. PV and GCP operational experience/auditing preferred.

Key Competency Requirements
  • Effective verbal and written communication skills in English. Ability to adapt communication style to suit different audiences/cultures. Deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients;
  • Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management, during the audit, inspection or process improvement process;
  • Ability to participate in the critical evaluation of quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations;
  • Good presentation skills, deliver focused message to audience of peers, stakeholders and Regulatory Agency Inspectors;
  • Profound knowledge of quality risk management. Ability to identify and escalate areas of high risk;
  • Demonstrates commitment to delivering high-quality work product;
  • Excellent knowledge of global, pre- and post-marketing regulatory requirements;
  • Good understanding of the drug development process;
  • Ability to analyze complex situations, and to draw meaningful conclusions, by distinguishing the details from the essence of the issue;
  • Ability to discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
  • Able to function independently within an environment that relies heavily on technology for information and communication;
  • Sense of diplomacy, discretion, confidentiality and security of information, data, documents and records;
  • Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
  • Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;
  • Ability to manage competing priorities;
  • Ability to lead change processes within functional group;
  • Possesses detailed knowledge of areas of expertise and could teach or mentor others;
  • Develops and applies new methods and ideas to enhance performance;
  • Software that must be used independently and without assistance (e.g., Microsoft Suite);
  • Demonstrates computer literacy; Microsoft Suite, SharePoint, Veeva Vault, other systems as assigned/applicable
  • Experience in data science and analytics, quality risk management and/or Six Sigma.

Travel Required

Approximately 25% travel to perform audits and attend professional meetings and seminars.

Approximately 5 overnight absences per month.

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

May potentially work inside of hospitals, laboratories and pharmacies while performing audits and inspections.

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.