Bristol-Myers Squibb Company

Associate Director, Global Packaging Quality

Location
New Brunswick, NJ, US
Posted
Apr 12, 2018
Ref
R1504451
Required Education
Bachelors Degree
Position Type
Full time
Summary:

Responsible for quality and compliance oversight of Global Packaging Technology (GPT) and Global Logistics Services (GLS) headquarters functions, support for network production sites conducting packaging operations, and sites and distribution centers using thermal protection transportation systems.

Serve as a member of the Device and Packaging Quality team, providing customer-based cross functional support in the areas of:
• Quality unit support to GPT and network sites to ensure that thorough deviation investigations, qualification studies, and risk assessments related to packaging and labeling/artwork are performed and documented
• support GPT engineers conducting technology transfer and new equipment implementation
• support GPT development of combination product packaging and related Design history file documentation required by 21CFR Part 4 cGMP for Combination Products
• establish and maintain Quality System Framework documents and procedures governing packaging and logistics operations across the network
• conduct audits of packaging suppliers and service providers.

Key Responsibilities include:
  • Provide global/above-site quality oversight and support to Network customers with respect to combination product and packaging design, development, commercialization, and post-commercialization activities; and qualification of thermal protection systems used to transport temperature-sensitive products.
  • Ensure compliance to CGMP, Good Distribution Practices (GDP), and BMS standards.
  • Ensure inspection readiness. Support audits of GPT, and GPS sites. Conduct periodic audits as defined.
  • Review and approve packaging strategy documents/master plans, user requirement specifications, design/operation/performance qualification protocols and reports, and technical assessments.
  • Author or coordinate the writing of comprehensive quality system documents. Initiate, update, review, or assist in the drafting of the quality manual, policies, directives, standard operating procedures and work instructions.
  • Ensure risk management is executed through Risk Management (RM) Plans, Risk Files, Hazard analyses, and risk analyses throughout the life cycle of the product. Ensure management oversight of RM activities.
  • Maintain consistent, effective communication with GPT and GMS sites, and suppliers/service providers through participation in project teams and the writing, implementation, and maintenance of Quality Agreements.
  • Generate, update or assist in the drafting of policies, procedures, and work instructions related to product quality metrics (e.g., risk assessment for product quality complaints, product quality complaint surveillance thresholds).
  • Provide internal or external training, as needed.
  • As requested, leads investigations and serves as a subject matter expert for quality events related to the development, manufacturing, packaging, storage, transportation and distribution of BMS products.
  • As requested, leads or supports market action fact-finding investigations for quality events that potentially impact product in the field.
  • Reviews and approves change control proposals, deviations, investigations, and corrective action/preventive action reports as part of quality support.
  • Serve as SME for evaluating the impact and applicability of new regulations via the PEARL process, as applicable.
  • Develop robust processes for Packaging Quality in collaboration with Global Packaging Technology, Manufacturing Science and Technology (MS&T) and Commercial Operations.
  • Seek opportunities to identify gaps and develop and implement cohesive solutions that benefit the broader organization. Drive continuous improvement.


Experience and Education:
  • The position requires a minimum of a Bachelor of Science degree in Engineering, Supply Chain, or Pharmacy. Specialization in Packaging and/or Logistics is preferred.
  • Minimum of 10 years experience in a Packaging Engineering, Quality Packaging Operations, Technical Services, or combination thereof

Knowledge:
  • Strong understanding of CGMP and GDP globally. In-depth knowledge of quality systems principles and applications.
  • Cross-functional experience including experience in Pharmaceutical or BioPharma manufacturing operations
  • Experience in supporting commercial manufacturing sites and HQ groups through global health authority inspections.
  • Demonstrated experience leading and contributing through influence and working in cross functional teams to investigate and manage quality and compliance related issues.
  • Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
  • Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
  • Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
  • Excellent oral and written communication skills.
  • Excellent influencing, facilitation and project management skills
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
  • Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
  • Capability to build alignment with business partners including research & development, commercial operations and manufacturing regional and site leaders
  • Pragmatic in approach with demonstrated ability to make sound, risk-based decisions
  • Ability to analyze and solve complex problems.
  • Ability to work independently and use initiative.
  • Ability to prioritize work and rapidly change priorities when necessary.
  • Ability to develop win/win solutions.
  • Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders