Associate Director, Quality Product Lead

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

POSITION SUMMARY

The Associate Director (AD) Quality Product Lead (e.g., QPL, Quality Product Steward) for BMS is the responsible Quality representative for the lifecycle of commercial products/brands for the Biologics/Sterile Fill and Pharma business units. The QPL, Product Quality, will serve as an individual contributor and as the primary Global Quality representative for Commercial Brands on the Brand matrix Global Operations (GO) Team. This individual will be responsible for the Lifecycle management of commercial products as a core member of the GO team and will be responsible for measuring, monitoring, and developing action plans related to Quality Brand Health.

Qualifications & Experience

• At least 8 years of experience in the industry (Pharma, biotech, generics, over the counter, device, animal health, and/or vaccines) and demonstrated combined leadership in Quality, technical experience, in depth knowledge of cGXP and regulatory expectations, quality and compliance processes, operations and strategy in the biopharmaceutical industry.
• The following would be considered advantageous but not required,
• Similar prior role in other industries (listed earlier)
• Lean six sigma, statistics, and/or business analytics certificate(s)
• A high-level understanding of integrated drug development of biologics and/or pharma compounds.
• Technical acumen in the areas of manufacturing and/or analytical testing of commercial brands
• Matrix team experiences
• Science minded, data driven and experience working in a matrix organization with Technical, Supply Chain, and/or Regulatory functional areas.
• Act on decisions while balancing quality, speed and rigor.
• Must be able to critically interpret problems, data and effectively communicate in an impactful manner to management, and the broader organization with clarity and a high level of brevity and accuracy.
• Must possess a strategic perspective, leading vision and values, global supply acumen, and leadership disposition to ensure continued supply through the brand strategy.
• Demonstrated Strategic and Analytical (structural/logical) thinking capability with project management skills, with the ability to focus on execution of decisions while balancing multiple priorities.
• Adapts to changing work environments, work priorities and organizational needs.
• Capable of interpretation of GMP regulations and guidelines
• Ensure sustainable compliance to corporate requirements as well as governmental regulations. Resolves problems of interpretation and administration of BMS policies and procedures.
• Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory)

As an Individual contributor:

• Serve as the core Quality member of the global Operations team (GO) as the single point of contact for the commercial brand, responsible and accountable to the brand team for overall success against the strategic plan (lifecycle, footprint, markets, format, risks, business continuity)
• Responsible for Commercial Brand Scorecards including continuous monitoring, data analysis, and reporting, leveraging the Quality systems and brand technical knowledge.
• Define and recommend actions to improve brand Quality Health through Scorecards based off data and trending.
• Approver of the global change management implementation plan, end-to-end preapproval inspection and launch readiness, responsibility for Right First Time (RFT) initial applications and post approval supplements for the late-stage early assets and Commercial brands. Responsible for compliance with approved licenses and approved market requirements.
• Responsible to drive and facilitate Drug shortage notifications to management and lead the process for endorsement and approval of HA (Health Authority) notifications.
• Evaluates impact of proposed post market changes on the end-to-end supply chain and develops, executes, and oversees change implementation strategies as the quality approver of global post marketing changes.
• Responsible for on time delivery of the E2E APQR for represented corresponding brands and aligning on any conclusions and or actions.
• Author Quality chapter for yearly brand strategy document for each commercial brand per schedule.
• May be the Lead investigator for complex global investigations. Responsible for ensuring that any required HA notifications are approved within notification timelines.

Qualifications & Experience

• At least 8 years of experience in the industry (Pharma, biotech, generics, over the counter, device, animal health, and/or vaccines) and demonstrated combined leadership in Quality, technical experience, in depth knowledge of cGXP and regulatory expectations, quality and compliance processes, operations and strategy in the biopharmaceutical industry.
• The following would be considered advantageous but not required,
• Similar prior role in other industries (listed earlier)
• Lean six sigma, statistics, and/or business analytics certificate(s)
• A high-level understanding of integrated drug development of biologics and/or pharma compounds.
• Technical acumen in the areas of manufacturing and/or analytical testing of commercial brands
• Matrix team experiences
• Science minded, data driven and experience working in a matrix organization with Technical, Supply Chain, and/or Regulatory functional areas.
• Act on decisions while balancing quality, speed and rigor.
• Must be able to critically interpret problems, data and effectively communicate in an impactful manner to management, and the broader organization with clarity and a high level of brevity and accuracy.
• Must possess a strategic perspective, leading vision and values, global supply acumen, and leadership disposition to ensure continued supply through the brand strategy.
• Demonstrated Strategic and Analytical (structural/logical) thinking capability with project management skills, with the ability to focus on execution of decisions while balancing multiple priorities.
• Adapts to changing work environments, work priorities and organizational needs.
• Capable of interpretation of GMP regulations and guidelines
• Ensure sustainable compliance to corporate requirements as well as governmental regulations. Resolves problems of interpretation and administration of BMS policies and procedures.
• Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).