Bristol Myers Squibb Company

Associate Director, Quality Engineering - Combination Products & Packaging

Location
Celgene, NJ, United States
Posted
Sep 03, 2020
Ref
R1522531
Required Education
Bachelors Degree
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.

PURPOSE AND SCOPE OF POSITION:

Reporting to the Senior Director, Device & Packaging Quality COE, the Associate Director, Quality Engineering - Combination Products & Packaging, is responsible for providing technical quality and compliance oversight and support to Manufacturing Science & Technology (MS&T), Product Development (PD) and Global Logistics Services (GLS). This position is an individual contributor role, providing customer-focused, cross-functional support to the following:
  • MS&T Packaging and Network sites to ensure appropriate investigations, studies and risk assessments are conducted.
  • MS&T Packaging Engineering functions conducting tech transfers and equipment installations
  • MS&T Packaging Development functions that design and commercialize combination product packaging in accordance with 21 CFR Part 4.
  • PD New Product Development teams that design and develop devices and combination products for global markets.
  • Global Audit Teams and Global Logistics Services serving as an Auditor or SME for audits of packaging suppliers and service providers.


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
  • Strong understanding of global cGMP and GDP standards and regulations with a focus on quality system and quality engineering principles.
  • Cross-functional experience within the healthcare space with device and pharmaceutical/biopharmaceutical experience required.
  • Significant experience and knowledge of combination product and device packaging technologies and methodologies spanning primary and secondary containers, inclusive of design, qualification and final validation of vials, pre-filled syringes, and dermal patches.
  • Proven experience leading CAPA investigation teams to provide solutions for commercial operations, manufacturing and distribution sites.
  • Experience in the use of continuous improvement methodologies and practices including Kepner-Tregoe problem solving, Lean and Six Sigma.
  • Expert knowledge of the regulatory and compliance requirements for design controls and combination products (21 CFR Part 4, 21 CFR Part 820, ISO 13485 and ISO 14971, 93/42/EEC).
  • Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 21 CFR part 600, 2010/83/EC and relevant ICH guidelines.
  • Proven knowledge in the use and implementation of packaging standards (ISTA 1A, 2A, 3A, 1G, ASTM D4169, D6198, etc.)
  • Experience in implementing cold chain solutions from production, packing, storage, global transportation, local storage, warehousing and transportation to point of sale/use.
  • Experience in implementing RFID and UDI packaging solutions and corresponding regulatory requirements for technologies to track and identify product.


DUTIES AND RESPONSIBILITIES
  • Provide global quality support and oversight across the BMS network with respect to combination product packaging and standard pharmaceutical primary containers (such as bottles and blisters). This includes all design, development, commercialization and post-commercialization activities.
  • Provide global quality support and oversight across the BMS network with respect to combination products, inclusive of packaging. This includes all design, development, commercialization and post-commercialization activities.
  • Serve as quality SME for products that require thermal protection systems and monitoring.
  • Ensure compliance to cGMPs, GDPs, QSRs and applicable BMS policies and standards
  • Support inspection readiness at all BMS network packaging operations and provide back/front-room support, as-needed, during third-party inspections.
  • Review and approve packaging strategy, development and commercialization documentation in accordance with applicable regulatory requirements.
  • Assist or perform risk assessments and analyses in accordance with product-specific risk management plans.
  • Assist or perform investigations and serve as technical quality SME for quality events related to the development, manufacture, storage, transport and/or distribution of BMS products as it relates to products and packaging.
  • Review and approves change control proposals, deviations, investigations and CAPAs as part of general quality support for MS&T and GLS.
  • As required, perform supplier on-site assessments or audits.
  • Ability to travel up to 20% globally.


EDUCATION AND EXPERIENCE

B.S. in an Engineering discipline (Packaging Engineering a plus); an advanced degree preferred; six-sigma certification preferred. Minimum 10 years relevant work experience, specifically in the regulated healthcare space (pharmaceuticals, biologics, or medical devices). Candidates with experience in the food industry may be considered for the position. Minimum 5 years of leadership experience.

WORKING CONDITIONS: (US Only)

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10%of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

DEFINITIONS AND ABBREVIATIONS (As Applicable) APPROVAL (on controlled copy)/ APPROBATION

(International Technical Operations / Quality Operations Only

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.