Core Hours: Monday - Friday, 8:00 am - 5:00 pmPurpose and ScopeThe Quality Compliance Manager provides leadership and direction for site compliance programs to ensure products meet established quality requirements and the site complies with applicable regulatory and company requirements. The Manager leads inspection readiness and administration; internal, supplier, corporate, customer, and regulatory audits; Quality Management Review and Quality Review Board programs; Annual Product Quality Reviews; Field Alert and other regulatory notifications; data integrity oversight; and recall readiness. The role also serves as the site authority on quality systems and compliance and ensures that manufacturing operations and the Quality Management System align with applicable U.S. and global requirements.
Essential Duties & ResponsibilitiesGeneral:- Provide site-level compliance leadership by deploying Quality Compliance programs that support company quality objectives and manufacturing operations.
- Serve as a knowledgeable site resource on quality systems, regulatory compliance, and the interpretation of applicable requirements.
- Maintain a culture of candid communication, accountability, collaboration, quality awareness, and continuous improvement across the Quality Compliance team, including employees working onsite or under an approved hybrid/remote arrangement.
- Direct the development and deployment of quality policies and procedures that meet regulatory and company requirements.
- Coach team members and identify development opportunities that keep the team current on applicable standards, regulatory expectations, and emerging industry trends.
- Represent Quality Systems & Compliance on cross-functional teams and collaborate with Manufacturing, Quality Control, Engineering, Facilities, Regulatory Affairs, local and global quality personnel, and external partners.
- Establish and support programs that promote quality awareness, inspection readiness, and sustained site compliance.
- Lead process improvements and standardize operating procedures by leveraging established quality systems and industry best practices.
- Perform other duties as assigned.
Inspection Readiness and Inspection/Audit Management:- Serve as the site Inspection Administrator and primary Quality Assurance lead for inspections and audits conducted by regulatory authorities, Corporate Auditing, customers, and marketing partners, including FDA routine surveillance and pre-approval inspections.
- Establish expectations and communication protocols for professional, cooperative interactions with FDA, other regulatory agencies, and clients, and assign the resources required to support each audit or inspection.
- Maintain continuous audit and inspection readiness through compliance monitoring, facility walkthroughs, staff alignment, quality-awareness activities, and training for subject matter experts and inspection participants.
- Manage GxP inspection administration and readiness programs, facilitate Inspection Readiness Steering Committee meetings, maintain organizational preparedness, and oversee the inspection-readiness budget.
- Coordinate cross-functional preparation strategies, readiness exercises, and mock audits to support effective execution during official visits.
- Lead front-room and back-room activities, document production, inspection communications, response preparation, and follow-up commitments.
- Lead the preparation and submission of formal responses and corrective action plans for regulatory findings, including those documented on FDA Form 483, ensuring responses are timely, accurate, complete, and compliant.
- Own the audit management process within the electronic quality management system (EQMS) and applicable inspection-management software.
- Develop, manage, and execute comprehensive, risk-based internal and supplier audit programs, including annual schedule approval, audit execution, reporting, CAPA follow-up, and budget alignment.
- Conduct or oversee complex internal, external, and supplier audits to evaluate manufacturing, quality, production, and support areas for compliance with cGMPs, company procedures, and other applicable requirements and to identify quality gaps, data-integrity risks, and compliance deviations.
- Maintain accurate and current records of audits, inspections, observations, investigations, and CAPAs, and oversee CAPA tracking to ensure timely and effective closure of findings.
- Escalate suspected or confirmed critical compliance issues to the Director of Quality Systems & Compliance and other designated leaders in accordance with established procedures, and recommend documented, risk-based containment, correction, and remediation actions.
Quality Compliance:- Evaluate assigned quality systems against applicable regulatory requirements and approved standards; identify gaps; establish or recommend remediation plans; and monitor implementation to support consistent site quality, compliance, and operational performance.
- Maintain expertise in and ensure compliance with applicable U.S. and international regulatory requirements and industry standards, including FDA, ICH, and relevant cGMP requirements.
- Own the Quality Management Review (QMR) and Quality Review Board (QRB) programs, including charters, governing procedures, presentation review, meeting cadence, and regulatory compliance.
- Review and approve key quality documents, including change controls, deviations, nonconformances, investigation reports, CAPAs, policies, procedures, and other critical QMS records.
- Monitor data-integrity compliance across site systems, document-control operations, and electronic records subject to FDA 21 CFR Part 11.
- Compile, analyze, and communicate significant quality and compliance metrics and trends to senior management through QMR and other governance forums, with recommendations for action.
- Ensure compliant and efficient systems for Field Alerts and other regulatory notifications, including reporting within required timeframes.
- Maintain a compliant recall system, lead mock recalls, and coordinate required communications with stakeholders and regulatory agencies.
- Provide quality support to affiliate partners and suppliers to promote a standardized approach to relevant GMP and GDP requirements.
- Collaborate with Regulatory Affairs and site leadership to interpret evolving regulatory expectations and implement appropriate policy, procedure, and system updates.
- Own the end-to-end Annual Product Quality Review (APQR) and Product Quality Review (PQR) processes from new product introduction through discontinuation, including schedule approval, data compilation, execution, report review, compliance verification, corrective action management, and management reporting.
- Ensure APQR and PQR reports are complete and aligned with applicable regulatory requirements, manufacturing data, batch records, established KPIs, and other relevant product quality information.
- Review critical product-quality metrics and trends and recommend risk-based continuous-improvement initiatives to senior leadership.
Leadership and Professional Development:- Directly manages assigned Quality Compliance employees and is accountable for workforce planning, selection, onboarding, work assignment, performance evaluation, coaching, development, and corrective action in accordance with company policy. The number and titles of direct reports may vary based on organizational needs. Set priorities, allocate resources, and oversee daily activities to ensure commitments, quality standards, and deadlines are met.
- Monitor performance, track progress against goals, conduct evaluations, and address performance concerns promptly and professionally.
- Assign projects and tasks with clear objectives, deadlines, and quality standards, and provide direct reports with the coaching, resources, and support needed to succeed.
- Establish team expectations for communication, collaboration, accountability, and professional development; monitor team effectiveness; and address barriers that affect performance, engagement, or compliance.
- Maintain expertise in regulatory and quality trends and model sound judgment, ethical conduct, and effective collaboration with internal and external stakeholders.
- Provide or support Good Documentation Practice (GDP) and GMP training for site personnel, as requested by Quality management.
Knowledge, Skills & Abilities- Extensive knowledge of U.S. and international regulatory requirements and standards applicable to pharmaceutical, biotechnology, biopharmaceutical, and, where relevant, medical device operations.
- Ability to apply applicable cGMP, GDP, GLP, data-integrity, and electronic-record requirements, including FDA 21 CFR Parts 210, 211, and 11.
- Extensive knowledge of company procedures and the ability to evaluate manufacturing, quality, production, and support areas for compliance with cGMPs and applicable business operating procedures.
- Ability to communicate effectively and cooperatively with regulatory agencies, clients, auditors, and senior leadership, including during high-pressure inspections and audits.
- Strong leadership and analytical capabilities, including the ability to independently evaluate complex compliance issues, interpret applicable requirements, assess risk, make recommendations within delegated authority, and escalate matters with significant product, patient, regulatory, or business impact.
- Ability to anticipate potential problems, investigate issues, assess risk, and recommend practical, compliant resolutions.
- Demonstrated ability to coordinate cross-functional projects, inspection-preparation activities, and compliance-improvement initiatives.
- Meticulous attention to detail when reviewing quality records for accuracy, completeness, and regulatory defensibility.
- Excellent written, verbal, interpersonal, presentation, and training skills, including the ability to prepare clear regulatory responses.
- High ethical standards, professional integrity, sound judgment, and the ability to influence cross-functional stakeholders.
- Ability to plan and lead internal, external, supplier, corporate, and customer audits and to manage regulatory inspections through preparation, execution, response, and follow-up.
- Proficiency with electronic quality and document-management systems, including EQMS and EDMS platforms, and the ability to create queries and reports.
Education & Experience- Bachelor's degree in science, engineering, life sciences, chemistry, or a related technical discipline is required. An advanced degree in a related discipline is preferred.
- Ten (10) or more years of progressive Quality Assurance, Regulatory Affairs, and/or compliance experience in a regulated pharmaceutical, biotechnology, biopharmaceutical, or medical device manufacturing environment is required, or an equivalent combination of directly related experience and an advanced degree.
- Five (5) or more years of inspection management and audit experience, including preparation for and hosting of regulatory inspections and management of internal, external, supplier, corporate, or customer audits, is required.
- Three (3) or more years of experience leading or managing quality-system elements such as deviations/nonconformances, CAPAs, internal audits, management review, and annual product quality reviews.
- Demonstrated experience interfacing effectively with FDA and other regulatory agencies is required.
- Relevant certifications-such as Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), ASQ Certified Supplier Quality Professional (CSQP), or Six Sigma-are preferred.
Working Conditions- This is a full-time onsite position. Working conditions are normal for an office environment.
- On-site management of all regulatory inspections and marketing partner audits is required.
- Some domestic and international travel may be required to support audits, inspections, and in-person collaboration with internal and external teams.
Compensation and Benefits- Annual pay range $135,000 - $145,000 depending on experience
- Bonus Eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
