Bristol-Myers Squibb Company

Manager, Global Product Quality Complaints

Location
New Brunswick, NJ, United States
Posted
Jul 22, 2019
Ref
R1514524
Required Education
Bachelors Degree
Position Type
Full time
Accountable for supporting the establishment of Quality systems for the global management of Product Quality Complaints and supporting their maintenance in accordance with GMPs, global health authorities' requirements and expectations.

Responsibilities:
  • Lead the design and implementation of a robust and compliant global framework of GMP policies, directives, procedures and processes for quality risk management for product quality complaints
  • Lead the establishment of a sustainable strategy for processes and procedures required for effective product quality complaint surveillance and investigation with Global Pharmacovigilance & Epidemiology
  • Oversee, monitor and improve reconciliation processes to confirm receipt and entry of product quality complaints from intake sources requiring reconciliation such as but not limited to Medical Information Contact Centers, and Global Pharmacovigilance & Epidemiology.
  • Lead the development and implementation of complaint investigation process improvements, liaise with ancillary groups for combination product/medical device complaints, oversee complaint quality risk management and surveillance activities for combination products, and participate in project teams as needed.
  • Oversight, coordination of activities and assignments of complaint management teams, ensuring timelines and goals are met.
  • Manage activities of the Product Quality Complaints Laboratory for investigation of customer-returned drug/device combination products
  • Assist in the coordination and compliance with requests of regulatory authorities during internal inspections and during inspections of contract service providers as needed.
  • Prepare complaint management and investigation reports, procedures and other documentation as needed.
  • Monitor pre-defined deliverables within the scope of this position on a monthly basis and make adjustments in anticipation of changes to internal business and regulatory environment.
  • Maintain awareness of evolving Product Quality Complaint global regulations and trends and implement systems to address potential GMP compliance impact
  • Communicate effectively and build cooperative and supportive working relationships with responsible Product Quality Complaints headquarter, Product Quality Complaint investigation and Global Pharmacovigilance & Epidemiology surveillance teams, sites, and cross-functionally across BMS
  • Active participation in pharmaceutical industry meetings, symposia, workshops to establish industry relationships, best practices and regulatory guidance as related to Product Quality Complaints
  • Support the establishment and maintenance of Global Quality Product Quality Complaint metrics
  • Identifies and recommends appropriate actions, activities and projects for continuous improvements
  • Perform other duties as required


Education:
Minimum of a Bachelor's degree or higher in Biological Sciences, Chemistry or related science or engineering discipline

Experience / Knowledge Desired:
• 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 authorities regulations and requirements
• A minimum of 5 years experience and in-depth knowledge of GMP requirements of Global Product Quality Complaint management

• Ability to effectively translate and communicate health authorities regulations
• Cross-functional experience in three or more areas (i.e. Quality Assurance, Manufacturing, Packaging Technology, Supply Chain, Regulatory, Pharmacovigilance, etc.) is required
• Experience with manager level interactions and influence with Manufacturing Operations, Pharmacovigilance, Regulatory, Medical Information, R&D and Supply Chain
• Experience in Pharmaceutical or Biotech Manufacturing Operations
• Collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites
• Experience in managing cross-functional teams
• Strong verbal and written communication skills
• Excellent influencing, facilitation and project management skills
• Subject matter expertise in regulatory requirements and expectations in Manufacturing, Pharmacovigilance, Quality Risk Management and/or Quality Assurance is required
• Capability to build alignment with business partners including, commercial operations, pharmacovigilance, medical information and investigation site leaders
• Strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities
• 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
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights