Leader Responsibilities

• 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

Duties & Responsibilities

• 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.

Regulatory Inspection Management:

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.

Client Audit Program:

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.

Internal Audit Program:

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.

Supplier Quality Management:

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.

Quality Metrics & Management Review Program:

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 development of annual quality objectives.

Monitor quality system health and identify compliance trends requiring escalation.

Provide compliance guidance to cross-functional teams.

Compliance Governance & Risk Management

Assess the effectiveness of Quality Management System processes through audit outcomes, inspection observations, quality metrics, management review outputs, and ongoing compliance monitoring activities

Partner with Quality Systems to ensure electronic quality systems, workflows, and associated controls support regulatory compliance and inspection readiness

Support and maintain the site’s Data Integrity Compliance Program

Provide assessments of computerized systems and data governance controls

Participate in investigations involving data integrity concerns

Promote risk-based decision making throughout the organization.

Facilitate quality risk assessments related to compliance, product quality, and patient safety.

Ensure risks are appropriately documented, mitigated, and escalated when necessary.

Support implementation of ICH Q9 principles within quality systems and operations.

Required Skills & Abilities

Broad knowledge of FDA and international regulations related to cGMPs and commercial drug product manufacturing.
Experience organizing and managing work responsibilities while working independently with minimal oversight.
Time and project management skills with the ability to multi-task and meet deadlines.
Excellent verbal and written communication skills. 
Excellent interpersonal and customer service skills. 
Excellent organizational skills and attention to detail.
Strong analytical and problem-solving skills.
Strong supervisory and leadership skills.
Ability to prioritize tasks and to delegate them when appropriate. 
Proficient with Microsoft Office Suite or related software.

Education & Experience

Bachelor's Degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or related discipline required. Advanced degree preferred.
Minimum 8 years of pharmaceutical, biotechnology, medical device, or CDMO quality experience.
Minimum 3 years of leadership experience within Quality Compliance, Quality Systems, or related quality functions.
Experience in supporting commercial manufacturing operations required.
Experience supporting FDA and / or EU regulatory inspections.
Demonstrated knowledge of cGMP regulations and quality system requirements.
Experience with electronic Quality Management Systems (eQMS).

Physical Requirements

Prolonged periods of sitting or standing at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
Adheres to consistent and predictable in-person attendance