Associate Director, Quality Systems and Compliance

Associate Director, Quality Compliance

Serán is seeking an Associate Director, Quality Compliance who will be responsible for leading the Quality Compliance program to ensure ongoing adherence to applicable GxP regulations, client requirements, industry standards, and internal Quality Management System (QMS) requirements. This role serves as the primary owner of inspection readiness, regulatory inspection management, client audit support, internal audit programs, supplier quality oversight, management review, quality metrics, and compliance monitoring activities.

The Associate Director partners closely with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, Engineering, Validation, and Quality Systems to foster a proactive quality culture and ensure sustainable compliance as the organization advances commercial manufacturing capabilities. This position serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to cGMP compliance oversight.

• Leads and develops a high-performing Quality organization
• Provides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy
• Establish clear departmental goals aligned with organizational quality and operational objectives
• Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
• Fosters a culture of quality ownership, compliance, and continuous improvement
• Oversees daily workflow of the department

• Lead the site's inspection readiness program and maintain a state of continuous readiness.
• Monitor evolving regulatory expectations and assess potential impacts to the Quality Management System.
• Conduct routine compliance assessments to identify gaps and opportunities for improvement.
• Drive remediation activities associated with inspection observations, compliance risks, and quality system weaknesses.
• Support implementation of compliance initiatives necessary to maintain commercial manufacturing readiness.

• Serve as Quality lead for health authority inspections.
• Coordinate inspection preparation activities across all functional areas.
• Lead inspection logistics, document management, response coordination, and inspection support activities.
• Facilitate timely and effective responses to regulatory observations.
• Track regulatory commitments through completion and effectiveness verification.

• Manage customer audit preparation and support activities.
• Partner with clients to facilitate quality due diligence, qualification, and surveillance audits.
• Coordinate audit logistics and observation responses.
• Track completion of corrective and preventive actions resulting from client audits.
• Trend audit observations to identify recurring compliance risks.

• Develop and maintain the annual internal audit schedule.
• Execute risk-based internal audits across manufacturing, laboratory, warehouse, engineering, supplier quality, and quality systems functions.
• Assess effectiveness of quality system implementation and compliance.
• Communicate audit findings and recommendations to management.
• Verify implementation and effectiveness of corrective actions.

• Manage the Supplier Qualification Program.
• Ensure risk-based qualification and monitoring of suppliers, contract laboratories, consultants, contractors, and critical service providers.
• Review supplier performance metrics and quality trends.
• Coordinate supplier audits and periodic evaluations.
• Support quality agreements and supplier quality governance activities.
• Escalate supplier-related quality risks to management.

• Coordinate and facilitate Site Management Review processes.
• Compile quality system performance data and compliance metrics.
• Present key compliance trends, risks, and quality indicators to leadership.
• Track management review actions through closure.
• Ensure management review activities support executive decision-making and resource planning.
• Develop and maintain compliance dashboards and performance metrics.
• Trend quality system performance and identify emerging compliance risks.
• Monitor key performance and compliance indicators including.
• Provide routine compliance updates to site leadership.
• Participate in…