Director, Quality Product Strategy (Devices)

MSD • Durham, NC

5d • Hybrid

About The Position

The Director, Quality Product Strategy (Devices) supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network. Ensures development and execution of a robust quality strategy for products supporting launch of the pipeline and/or uninterrupted supply of commercial products. Scope of responsibilities includes value chain management team (VCMT) member, franchise support of late stage pipeline Quality activities as well as inline quality related issues, sponsored project support and strategic network changes (e.g. expansion and supply chain robustness) for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader. Primary Activities Primary activities include, but are not limited to: Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils. Strategic elements include inspection and launch readiness for pipeline products and testing and quality strategies (product analytical strategy), risk mitigation, issue resolution, network expansion, supply chain robustness at the global franchise level. Act as a quality designee for global product quality as needed. Ensures prioritization, progress, and escalation, as appropriate, of quality related strategic goals (including strategy, efficiency and compliance related items) through periodic reviews and dashboard across products and manufacturing/testing sites across the network. Lead and/or participate in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division. Review and approve, as appropriate, franchise level documentation including but not limited to: Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise level protocols/reports, filing/license submissions, franchise level regulatory observation responses, RTQs, franchise level change control, site and multi-site investigations, where appropriate. Leads/coordinates Quality Working Group meeting for the franchise, where applicable and serves as the Quality Representative to DCT/VCMT and associated working groups, where applicable. Collaborate with Quality leads to resolve supply chain quality issues. Collaborates with QMS Chapter leads and document owners to define, refine and standardize quality requirements. Identifies any gaps in QMS requirements that are critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement to QMS documents. Track metrics (change control, complaint, etc.) for the franchise. Evaluate the franchise's Annual Product Review for supply chain trends and escalate risks as necessary. Actively participate and escalate issues/risk to the Quality sponsors and via IRM as required and identify need for and support development of Analytical Siting decisions. Monitor and mitigate franchise Quality risks. Participate in inspections as required and champion Permanent Inspection Readiness (PIR) for the product program.

Requirements

• Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics with minimum of twelve (12) years of experience including quality oversight roles including technical elements or technical operations roles.
• Minimum of 2 years direct experience with supply chain strategy or technical elements (e.g. change controls, investigations, process documentation (e.g. protocols, CPV, etc.), preferably with small molecule products.
• Demonstrated skills for external facing communications in written and verbal form.
• Demonstrated success leading multi-functional teams driving continuous improvement and execution of strategic actions across a network (i.e. multiple groups/sites/functions).
• Travel is approximately 10%.
• Entrepreneurship/Innovation: Meeting patient and customer and organization’s needs by confronting difficult issues, offering creative alternatives and taking action.
• Decision Making/Influence: Identifying and understanding problems; gathering, analyzing and interpreting information, establishing decision criteria, and identifying alternatives. Making timely decisions using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
• Growth/Development/Change: Using new knowledge and skills on the job and learning through application. Modifying behavior based on self-awareness to improve impact and adaptability for major changes in work or environment (e.g., people, processes, structure or culture), trying new approaches.
• Networking/Inclusion: Building partnerships; developing and leveraging relationships within and across work groups to achieve results. Working effectively across cultures, interpersonal styles, perspectives, motivations or backgrounds.
• Execution Excellence/Ownership/Inspiration: Being proactive and setting high standards of performance for self and others; completing assignments or tasks; communicating effectively, clearly and concisely helping stakeholders understand and retain the message; listening actively.
• Analytical Thinking, Collaboration, Communication, Cross-Functional Work, Global Supply Chain Strategy, Inspection Readiness, Medical Devices, Product Quality, Quality Assurance (QA), Quality Mindset

Responsibilities

• Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils.
• Strategic elements include inspection and launch readiness for pipeline products and testing and quality strategies (product analytical strategy), risk mitigation, issue resolution, network expansion, supply chain robustness at the global franchise level.
• Act as a quality designee for global product quality as needed.
• Ensures prioritization, progress, and escalation, as appropriate, of quality related strategic goals (including strategy, efficiency and compliance related items) through periodic reviews and dashboard across products and manufacturing/testing sites across the network.
• Lead and/or participate in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division.
• Review and approve, as appropriate, franchise level documentation including but not limited to: Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise level protocols/reports, filing/license submissions, franchise level regulatory observation responses, RTQs, franchise level change control, site and multi-site investigations, where appropriate.
• Leads/coordinates Quality Working Group meeting for the franchise, where applicable and serves as the Quality Representative to DCT/VCMT and associated working groups, where applicable.
• Collaborate with Quality leads to resolve supply chain quality issues.
• Collaborates with QMS Chapter leads and document owners to define, refine and standardize quality requirements.
• Identifies any gaps in QMS requirements that are critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement to QMS documents.
• Track metrics (change control, complaint, etc.) for the franchise.
• Evaluate the franchise's Annual Product Review for supply chain trends and escalate risks as necessary.
• Actively participate and escalate issues/risk to the Quality sponsors and via IRM as required and identify need for and support development of Analytical Siting decisions.
• Monitor and mitigate franchise Quality risks.
• Participate in inspections as required and champion Permanent Inspection Readiness (PIR) for the product program.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees