Associate Director, Quality Assurance

About this role

Job Description

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. Essential functions include but are not limited to in partnership with GLP QA Functional and Operation Leads, support the implementation and management of the QA strategy. Independently facilitates specific tasks in compliance with appropriate government regulations (e.g., FDA GLPs, OECD guidelines), guidance documents, Company policies, and departmental Standard Operating Procedures (SOPs). This position is responsible for the execution and closure of the assigned global GLP QA audit activities ensuring that the current regulations, policies, and procedures are adhered to at all our company's sites (domestic and international) and at contract facilities worldwide. Assignments are of increased complexity and solves complex problems. Will function as a team or project lead as required promoting open discussion of issues. Primary Responsibilities: • Facilitates communication and alignment with key stakeholders upstream and downstream.

• Conducts wide range of GLP, regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits in accordance with QA risk-based processes. regulations/guidelines, as well as our Company policies, procedures, and industry standards.

• Serves as a Lead Liaison for all QA activities supporting regulated activities within our Company sites (domestic and international) and contract facilities worldwide.

• Provides 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 functions as a lead auditor to ensure compliance to regulations, international guidelines, our Research & Development Division policies, and departmental SOPs in accordance with QA SOPs. Provide regulatory perspective or quality advice and guidance to the stakeholder areas and within QA.

• Works independently by seeking guidance only in the most complex situations. Makes decisions guided by policies in non-standard situations which impacts the achievement of client, customer, operational, project or service objectives. Manages own work to meet competing priorities and deadlines (stakeholder and GLP QA). Documents and and/or tracks audits and inspections as required. Assures timely resolution of findings and reports all findings to appropriate personnel and management.

• Maintain expert-level knowledge of all applicable regulations and guidelines worldwide, as applicable to stakeholders, and ensure the current regulations, policies and procedures are adhered to. Reviews and interprets, using own discretion, regulatory citations and other pertinent information and distributes to appropriate personnel. Acts as a resource for colleagues across areas. Explains difficult concepts and influences others to adopt a different point of view, when appropriate

• Develops, coordinates and/or conducts education and training on compliance requirements for our Research & Development Division or other stakeholder personnel when needed. Provides training and mentorship to less experienced QA staff. Provides project specific feedback as appropriate. Leads and or participates 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. Solves/leads others to solve complex problems; takes a broad perspective to identify innovative solutions.

• Leads appropriate and timely escalation of quality issues, including issues of significant deviation with projects, to the Functional Lead and GLPQA Head. Participates in the assessment of potential root cause and Corrective Actions Preventive Actions (CAPAs) associated with Significant Quality Issues, as needed.

• Key point person during inspection management and provides independent support as appropriate.

• Represents GLP QA and or QA on interdivisional and cross-functional teams, as needed.

Education: • Minimum Required: Bachelor's Degree in appropriate Science, IT or Engineering discipline.

Required :    • 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.

Preferred :    • Experience with computer system applications (e.g., Pristima, electroni

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