Executive Director, Quality Assurance
Merck · Rahway, NJ · 3 wk ago
$210k–$331k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where content exists.
We must not repeat job title. Remove boilerplate: cookie/navigation/legal/EEO etc. Also remove application instructions, duplicated lines, etc.
We need to preserve substantive info.
Let's parse the job description.
First paragraph: "Job Description The Global Quality Group within the Manufacturing Division is seeking an experienced Leader to provide strategic oversight and direction for a complex, enterprise-level transformation program. This project aims to transform QC testing to support our pipeline and in-line supply products. The project has significant innovation components including end-to-end analytical digitization, analytical instrumentation innovation, lab automation, standardized laboratory workflows, and a digitized QMS and lab operations system. The Quality Lead, in collaboration with the project leadership team, will oversee integrated planning, governance, and execution across a highly matrixed project, ensuring alignment to GxP requirements while incorporating novel technical and digital laboratory components and delivery of key program outcomes. They will partner with executive leadership, business stakeholders, cross-functional teams and external partners, as necessary, to manage interdependencies, support timely decision-making, and advance the program from project planning to regulatory filing and approval and through operational transition and sustainment. They will be a key input to an integrated plan that includes Technology Development, Analytical Development, Quality and Compliance, Regulatory, IT and external partners all collaborating seamlessly to deliver a scalable, compliant, and future-ready model, all within an aggressive timeline."
That's about the role. Could be "About the role" section.
Next: "Key Responsibilities And Requirements The ideal candidate can meld strong technical skills and an innovation mindset to set strategic Quality direction and compliantly translate it into an integrated, end-to-end program plan while managing and executing that plan across milestones, dependencies, and the critical path. This role is responsible for directing decision forums that enable alignment and remove barriers, while proactively managing risks, assumptions, constraints, and interdependencies across highly matrixed, cross-functional teams. Acting as the connective link between executive sponsors and delivery teams, the candidate provides clear, data-driven insights and recommendations, drives technology and operating model transformation, and ensures alignment with quality and regulatory requirements. Success in this role requires a structured, analytical leader with strong stakeholder and communication skills, an innovation mindset, a focus on measurable value realization, and the ability to enable adoption and transition outcomes into sustainable operations. A strong background in analytical development, analytical testing and automation validation within a GMP laboratory is expected. The role will also need to have expert level leadership to supervise Quality and other personnel in direct support of the cross-functional program goals."
That's responsibilities and requirements combined. We can split: Responsibilities (list) and Requirements (list). We'll need to extract bullet points.
Let's extract responsibilities:
- Provide strategic oversight and direction for enterprise-level transformation program.
- Oversee integrated planning, governance, execution across highly matrixed project, ensuring alignment to GxP while incorporating novel technical/digital lab components.
- Partner with executive leadership, business stakeholders, cross-functional teams, external partners to manage interdependencies, support timely decision-making, advance program from planning to regulatory filing/approval and through operational transition and sustainment.
- Be key input to integrated plan including Technology Development, Analytical Development, Quality and Compliance, Regulatory, IT, external partners to deliver scalable, compliant, future-ready model within aggressive timeline.
- Direct decision forums that enable alignment and remove barriers.
- Proactively manage risks, assumptions, constraints, interdependencies across highly matrixed cross-functional teams.
- Act as connective link between executive sponsors and delivery teams; provide clear, data-driven insights and recommendations; drive technology and operating model transformation; ensure alignment with quality and regulatory requirements.
- Enable adoption and transition outcomes into sustainable operations.
- Supervise Quality and other personnel in direct support of cross-functional program goals.
Now requirements (experience, education, etc.):
- Bachelor’s degree required; advanced degree (PhD, MBA, PharmD, or equivalent) strongly preferred.
- 15+ years of relevant experience in quality, pharmaceutical development, manufacturing and science technical operations, or related biopharmaceutical functions.
- Leadership experience with CGMP testing laboratories subject to FDA inspections.
- Demonstrated experience utilizing an innovative mindset to challenge the status quo and improve workflows.
- Experience in development and implementation of laboratory technology.
- Experience in GxP, quality, and compliance-driven management programs.
- Strong program governance, structured execution, and analytical skills.
- Excellent communication, stakeholder management, and executive presentation skills.
- Proven experience leading enterprise-level technology transformation or lab innovation programs.
- Ability to manage multiple priorities and complex interdependencies effectively.
- Strong understanding of regulated, scientific, technical, or IT/program environments.
- Financial acumen, including budgeting, forecasting, and value tracking.
- Proven ability to build alignment across internal and external cross-functional teams.
Preferred Experience (list):
- Programming experience will be an asset.
- Experience in research and development within the pharmaceutical industry and in clinical phase Quality expectations.
- Experience supporting workforce strategy, technology evaluation, or enterprise transition initiatives.
- Experience working directly with third party technology providers.
- Experience with filing and registering new products.
- Experience with stage gate or capital governance models.
Skills list: a long list of skills (some repeated). We need to include Skills section if there is real specific content. The list includes many items: Ability to Coordinate (twice), Analytical Thinking, Aseptic Manufacturing, Competency Management, Conflict Resolution, Cross-Cultural Awareness, Cross-Functional Project Management, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Financial Acumen, Innovation Management, Leadership Project Management, Legal Compliance, Microbiology, Organizational Change Management, People Leadership, Performance Plans, Process Alignment, Process Innovation, Product Lining, Project Integration, Project Management Leadership, Project Planning {+ 9 more}. We'll need to extract them as list items.
We also have Pay: "The salary range for this role is $210,400.00 - $331,100.00". Also mention bonus and long-term incentive. So Pay section.
Benefits: "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."
Schedule: Not explicitly mentioned. There's "Relocation: VISA Sponsorship Travel Requirements: Flexible Work Arrangements Hybrid Shift". That indicates schedule/hybrid. Could be considered Schedule. The posting mentions "Hybrid Shift". So we can include Schedule section with "Hybrid work arrangement (flexible)". Also "Relocation: VISA Sponsorship Travel Requirements: Flexible Work Arrangements Hybrid Shift". We'll extract schedule info: Hybrid work arrangement, flexible work arrangements, relocation, visa sponsorship, travel requirements.
We must not include boilerplate like EEO, accommodation, etc. Also remove "Current Employees apply HERE", etc. Remove "US And Puerto Rico Residents Only". Remove "Search Firm Representatives". Remove "Job Posting End Date" etc. Remove "Requisition ID". Remove "Job Description" heading.
We must preserve all substantive info. So we need to include the salary range, benefits, schedule info.
Now produce HTML fragment with headings for each section.
We'll have sections: About the role, Responsibilities, Requirements, Preferred Experience (maybe combine with Requirements? But we have separate sections for Qualifications? The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can map:
- About the role: intro paragraph.
- Responsibilities: list of responsibilities.
- Requirements: required experience/education (maybe also qualifications). Could split Requirements and Qualifications but we have limited content. We'll put required experience under Requirements, and maybe qualifications under Qualifications (like degree, advanced degree preferred). But we can combine. However we need to avoid empty sections. We'll create Requirements for required experience and qualifications (education). Qualifications could be for preferred experience? Actually preferred experience is separate. We could put preferred experience under Qualifications. But we have also Skills section.
Let's decide:
- About the role: intro.
- Responsibilities: bullet list.
- Requirements: required experience (Bachelor's degree required, 15+ years, etc.)
- Qualifications: preferred experience (programming experience, R&D, etc.) maybe also advanced degree preferred? But advanced degree is already in requirements as strongly preferred. Could still be there. We'll keep Qualifications for preferred experience and advanced degree.
- Skills: list of skills.
- Benefits: bullet list.
- Pay: paragraph with salary range and bonus.
- Schedule: paragraph with hybrid, flexible, relocation, visa sponsorship, travel.
We must not include sections with filler like "commensurate with experience". We have real content.
Now produce HTML.
We'll need to escape any special characters? Not needed.
Let's craft.
for each section.
We'll have sections: About the role, Responsibilities, Requirements, Preferred Experience (maybe combine with Requirements? But we have separate sections for Qualifications? The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can map:
- About the role: intro paragraph.
- Responsibilities: list of responsibilities.
- Requirements: required experience/education (maybe also qualifications). Could split Requirements and Qualifications but we have limited content. We'll put required experience under Requirements, and maybe qualifications under Qualifications (like degree, advanced degree preferred). But we can combine. However we need to avoid empty sections. We'll create Requirements for required experience and qualifications (education). Qualifications could be for preferred experience? Actually preferred experience is separate. We could put preferred experience under Qualifications. But we have also Skills section.
Let's decide:
- About the role: intro.
- Responsibilities: bullet list.
- Requirements: required experience (Bachelor's degree required, 15+ years, etc.)
- Qualifications: preferred experience (programming experience, R&D, etc.) maybe also advanced degree preferred? But advanced degree is already in requirements as strongly preferred. Could still be there. We'll keep Qualifications for preferred experience and advanced degree.
- Skills: list of skills.
- Benefits: bullet list.
- Pay: paragraph with salary range and bonus.
- Schedule: paragraph with hybrid, flexible, relocation, visa sponsorship, travel.
We must not include sections with filler like "commensurate with experience". We have real content.
Now produce HTML.
We'll need to escape any special characters? Not needed.
Let's craft.
About the role
The Global Quality Group within the Manufacturing Division is seeking an experienced Leader to provide strategic oversight and direction for a complex, enterprise-level transformation program. This project aims to transform QC testing to support our pipeline and in-line supply products. The project has significant innovation components including end-to-end analytical digitization, analytical instrumentation innovation, lab automation, standardized laboratory workflows, and a digitized QMS and lab operations system. The Quality Lead, in collaboration with the project leadership team, will oversee integrated planning, governance, and execution across a highly matrixed project, ensuring alignment to GxP requirements while incorporating novel technical and digital laboratory components and delivery of key program outcomes. They will partner with executive leadership, business stakeholders, cross-functional teams and external partners, as necessary, to manage interdependencies, support timely decision-making, and advance the program from project planning to regulatory filing and approval and through operational transition and sustainment. They will be a key input to an integrated plan that includes Technology Development, Analytical Development, Quality and Compliance, Regulatory, IT and external partners all collaborating seamlessly to deliver a scalable, compliant, and future-ready model, all within an aggressive timeline.
Responsibilities
- Provide strategic oversight and direction for the enterprise-level transformation program.
- Oversee integrated planning, governance, and execution across a highly matrixed project, ensuring alignment to GxP while incorporating novel technical and digital laboratory components.
- Partner with executive leadership, business stakeholders, cross-functional teams, and external partners to manage interdependencies, support timely decision-making, and advance the program from planning to regulatory filing/approval and through operational transition and sustainment.
- Serve as a key input to an integrated plan that includes Technology Development, Analytical Development, Quality and Compliance, Regulatory, IT, and external partners to deliver a scalable, compliant, and future-ready model within an aggressive timeline.
- Direct decision forums that enable alignment and remove barriers.
- Proactively manage risks, assumptions, constraints, and interdependencies across highly matrixed, cross-functional teams.
- Act as the connective link between executive sponsors and delivery teams; provide clear, data‑driven insights and recommendations; drive technology and operating model transformation; ensure alignment with quality and regulatory requirements.
- Enable adoption and transition outcomes into sustainable operations.
- Supervise Quality and other personnel in direct support of cross‑functional program goals.
Requirements
- Bachelor’s degree required; advanced degree (PhD, MBA, PharmD, or equivalent) strongly preferred.
- 15+ years of relevant experience in quality, pharmaceutical development, manufacturing and science technical operations, or related biopharmaceutical functions.
- Leadership experience with CGMP testing laboratories subject to FDA inspections.
- Demonstrated experience utilizing an innovative mindset to challenge the status quo and improve workflows.
- Experience in development and implementation of laboratory technology.
- Experience in GxP, quality, and compliance‑driven management programs