Associate Director, Quality Assurance

MSD•Upper Gwynedd Township, PA

2d•$129,000 - $203,100•Hybrid

About The Position

Our Research and Development division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research Quality (RQ) encompasses several functional quality groups who focus on technology and systems, suppliers, and internal processes. The functions perform both proactive quality oversight activities and auditing and provide support to strategic initiatives across our Research and Development division. The Good Laboratory Practice (GLP) team provides independent quality oversight assuring that the company’s non -clinical studies and internal clinical analyses are conducted in compliance with regulatory expectations.

Requirements

Bachelor's Degree in appropriate Science, IT or Engineering discipline.
Minimum 8 years of audit experience in the regulated pharmaceutical, biopharma/biologics or related industry.
Extensive knowledge of FDA and OECD GLP regulations.
Experience leading audits.
Strong leadership skills and the ability to lead cross-functional teams.
Experience using electronic quality systems to monitor, report and track quality tasks and key performance indicators.
Excellent attention to detail.
Proficient with digital tools and computer applications; competency in Microsoft PowerPoint, Excel, and Word.
Excellent verbal and written communication and presentation skills.
Ability to independently prioritize and manage multiple projects and tasks simultaneously, ensuring timely delivery and meeting business objectives.
Audit Management
Collaborative Leadership
Project Leadership
Quality Assurance Systems
Quality Oversight
Regulatory Compliance

Nice To Haves

Experience with computer system applications (e.g., Pristima, electronic laboratory notebooks, Veeva, Laboratory Information Management Systems (LIMS), Empower).
Experience leading and/or supporting US and EU health authority inspections.
Superior collaboration and teamwork skills.
Experience with Pristima, electronic laboratory notebooks, Veeva, Laboratory Information Management Systems (LIMS), Empower.

Responsibilities

Support the implementation and management of the QA strategy in partnership with GLP QA Functional and Operation Leads.
Independently facilitate specific tasks in compliance with appropriate government regulations (e.g., FDA GLPs, OECD guidelines), guidance documents, Company policies, and departmental Standard Operating Procedures (SOPs).
Execute and close assigned global GLP QA audit activities ensuring that current regulations, policies, and procedures are adhered to at all company sites (domestic and international) and at contract facilities worldwide.
Facilitate communication and alignment with key stakeholders upstream and downstream.
Conduct a wide range of GLP, regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits in accordance with QA risk-based processes, regulations/guidelines, as well as company policies, procedures, and industry standards.
Serve as a Lead Liaison for all QA activities supporting regulated activities within company sites (domestic and international) and contract facilities worldwide.
Provide expert-level knowledge of assigned major project/program areas as related to quality assurance issues and strategies.
Responsible for the daily activities for assigned projects/programs, including prioritizing, planning, scheduling, monitoring, and communicating issues to appropriate personnel.
Independently function as a lead auditor to ensure compliance to regulations, international guidelines, company Research & Development Division policies, and departmental SOPs in accordance with QA SOPs.
Provide regulatory perspective or quality advice and guidance to stakeholder areas and within QA.
Make decisions guided by policies in non-standard situations which impacts the achievement of client, customer, operational, project or service objectives.
Manage own work to meet competing priorities and deadlines (stakeholder and GLP QA).
Document and/or track audits and inspections as required.
Assure timely resolution of findings and report all findings to appropriate personnel and management.
Maintain expert-level knowledge of all applicable regulations and guidelines worldwide, as applicable to stakeholders, and ensure current regulations, policies and procedures are adhered to.
Review and interpret, using own discretion, regulatory citations and other pertinent information and distribute to appropriate personnel.
Act as a resource for colleagues across areas.
Explain difficult concepts and influence others to adopt a different point of view, when appropriate.
Develop, coordinate and/or conduct education and training on compliance requirements for the Research & Development Division or other stakeholder personnel when needed.
Provide training and mentorship to less experienced QA staff.
Provide project-specific feedback as appropriate.
Lead and/or participate on department committees supporting internal functions and/or evaluating business processes for improvement opportunities.
Manage large or multiple projects with moderate resource requirements, risk and/or complexity as directed by management.
Solve/lead others to solve complex problems; take a broad perspective to identify innovative solutions.
Lead appropriate and timely escalation of quality issues, including issues of significant deviation with projects, to the Functional Lead and GLPQA Head.
Participate in the assessment of potential root cause and Corrective Actions Preventive Actions (CAPAs) associated with Significant Quality Issues, as needed.
Act as key point person during inspection management and provide independent support as appropriate.
Represent GLP QA and/or QA on interdivisional and cross-functional teams, as needed.