Bristol-Myers Squibb Company

Manager, Global Product Quality Complaints

Location
New Brunswick, NJ, US
Posted
May 25, 2018
Ref
R1506921
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a qualified and motivated team player to lead Global Product Quality Complaint (PQC) operations, responsible as a primary contact and support for Medical Information Contact Centers, Global Pharmacovigilance, and other sources responsible for PQC intake to provide quality and compliance oversight for these processes. Manage external partner relationship and assist with the identification of inefficiencies and implementation of solutions. Enhance and implement role based PQC training programs for external and internal stakeholders. Support the management of the global complaint handling process from receipt to closure ensuring quality & compliance with internal and regulatory requirements. Assist in establishment of Quality Risk Management principles in evaluation and investigation of PQCs

Bristol-Myers Squibb is the industry leader in immuno-oncology with life-saving medicines and a rich clinical portfolio of diverse modalities including monoclonal antibody, antibody drug conjugate, fusion protein, and combination regimes. The candidate will have the opportunity to actively contribute to the value that the company brings to our patients.

Position Responsibilities:

• Provide ongoing assessment of PQC programs and processes related to the intake of PQCs, determine the appropriateness of processes, improve and implement as appropriate.

• Lead the improvements for product return and product replacement processes required for PQC investigation.

• Provide support of Adverse Event (AE)/PQC surveillance processes with Global Pharmacovigilance & Epidemiology (GPVE)

• Develop and implement role based PQC training programs

• Identify critical quality issues, escalate through appropriate quality systems and assist in the review and determination of the acceptability of deviation reports and proposed corrective action plans for PQC intake processes and procedures.

• Develop trusting, open and collaborative partnerships while ensuring suppliers have a clear understanding of company's quality requirements through established Statements of Work

• Provide experienced based training to internal and external personnel to ensure compliance with regulations

• Manage all aspects of complaint handling from receipt to closure as necessary

• Assist in the establishment of quality risk management for complaint handling and promote the understanding of risk management for product quality complaints

• Manage all aspects of quality system requirements, such as good documentation practices, maintenance of standard operating procedures (SOP), trainings, change controls, quality agreements and computer system validations as necessary for complaint handling

• Establish and generate complaint metrics and Key Performance Indicators (KPIs) to facilitate improvements for end-to-end complaint process

• Support Product Surety and Serialization activities as necessary

Competencies - Knowledge, Skills, Abilities:
  • Subject matter expertise in regulatory requirements and expectations for management of PQCs is required
  • Strong project management expertise and ability to focus on execution of strategic decisions while balance conflicting priorities
  • Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments


Experience - Responsibility and minimum number of years:

A minimum of 10 years of pharmaceutical industry experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of global health authority's regulations and requirements. Experience working with product quality complaints involving global teams highly desirable. People management experience preferred.

Qualifications:

Degree/Certification/Licensure

Minimum of a Bachelor's Degree required; Health Sciences, Pharmacy or Chemical or Bio-Medical Engineering preferred. ASQ Certification in Quality Auditing or Quality Management preferred.