Quality Program Manager

Customer Quality Relationship Management

• Serve as the primary Quality point of contact for assigned customer programs.
• Develop and maintain strong working relationships with Customer Quality, Technical Operations, Regulatory and Supply Chain representatives.
• Partner with Project Management in customer governance meetings, project reviews and escalation discussions to provide quality perspective, compliance guidance and risk assessments.
• Lead customer discussions involving quality systems, investigations, change controls, validation activities, product quality concerns and regulatory compliance matters.
• Ensure customer notification requirements are fulfilled in accordance with Quality Agreements and regulatory expectations.
• Support customer audits, site visits, due diligence assessments and quality-related business discussions.

New Product Introduction and Technology Transfer

• Provide Quality oversight and strategic guidance for New Product Introduction (NPI), technology transfer, and commercialization activities.
• Participate in project planning activities to ensure appropriate quality support and risk management strategies are established.
• Coordinate quality deliverables required to support product transfers, process validation, analytical method transfers, cleaning validation and commercial launch activities.
• Assess quality and compliance risks associated with new products, manufacturing processes, facilities, equipment and analytical methods.
• Provide Quality input into transfer assessments, validation strategies and product control strategies.
• Ensure quality requirements are appropriately incorporated into project execution plans and timelines.

Quality Systems Coordination

• Coordinate quality support activities impacting assigned customer programs, including deviations and investigations, CAPAs, change controls, risk assessments, product impact assessments, validation activities, customer notifications, product complaints, Annual Product Reviews / Product Quality Reviews, and regulatory commitments.
• Facilitate cross-functional discussions to ensure timely resolution of quality issues and customer concerns.
• Monitor quality system performance and communicate issues that may impact project milestones, product quality, regulatory compliance or customer commitments.

Compliance and Regulatory Support

• Provide guidance on applicable FDA, EMA, Health Canada, ICH, and global cGMP requirements related to sterile pharmaceutical manufacturing.
• Support regulatory inspections, customer audits and remediation activities related to assigned programs.
• Evaluate quality and compliance risks and recommend appropriate mitigation strategies.
• Ensure activities supporting customer programs are conducted in accordance with internal procedures, regulatory requirements and approved Quality Agreements.

Cross Functional Program Support

• Act as the Quality counterpart to PMO, ensuring quality activities remain aligned with overall program objectives and timelines.
• Collaborate with Manufacturing, QC, Validation, Technical Services, Regulatory Affairs, Supply Chain, Engineering and Project Management to support successful program execution.
• Escalate quality risks, compliance concerns and resource constraints that may impact project deliverables.
• Provide leadership and coordination during issue resolution activities involving quality-related customer concerns.

Continuous Improvement

• Identify opportunities to improve NPI processes, technology transfer activities, customer-facing quality systems and cross-functional collaboration.
• Drive standardization and best practices for Quality support of customer programs.
• Support development and reporting of quality performance metrics associated with customer projects and new product introductions.
• Read/interpret SOPs to ensure compliance.
• Maintain up to date trainings.

Other Skills and Abilities

• Fosters a collaborative and positive work environment.
• Champions change.
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail.
• Ability to analyze complex technical, quality, operational and project-related information and apply risk-based decision-making principles.
• Ability to interpret quality metrics, statistical trending, validation data, process performance data and compliance information to identify risks and support business decisions.