This role provides independent Quality oversight and governance of engineering, manufacturing, and technical support activities. This role ensures that outputs generated by Operations, Facilities & Engineering, and MSAT meet cGMP, regulatory, and internal quality standards. The position is responsible for the review and approval of QMS records, investigations, protocols, technical reports, and system deliverables.
The Manager plays a key role in maintaining a robust Quality Management System (QMS) and ensuring inspection readiness, supporting the reliable supply of high-quality sterile injectable and combination products.
Essential Duties and Responsibilities:
· Provide leadership, direction, and support to the people within Quality Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated, and carry out their duties in a safe manner.
· Establish and maintain the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes by working across functions.
· Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality-related matters are provided to the site.
· Provide Quality oversight for documentation supporting combination product and device-related activities. Ensure compliance with applicable regulatory expectations (e.g., 21 CFR Part 4 where applicable).
· Review and approve transfer-related documentation to ensure completeness, traceability, and compliance. Ensure alignment between sending and receiving site documentation.
· Oversee and approve maintenance records, calibration records, and system outputs for compliance and data integrity within the Computerized Maintenance Management System (CMMS).
· Provide quality oversight for calibration and maintenance programs and ensure they are developed and run in accordance with GMP regulations.
· Review and approve protocols, reports, and investigations associated with automated inspection systems.
· Review and approve deviations and investigations related to engineering systems, utilities, equipment, and manufacturing operations.
· Ensure root cause analysis, impact assessments, and CAPAs are appropriate and effective.
· Oversee trending reports and quality metrics generated by technical and operational functions as it relates to the Quality Engineering oversight.
· Ensure data is accurately trended and supports effective decision-making and continuous improvement.
· Review and approve documentation related to automation systems, ensuring appropriate controls, traceability, and compliance.
· Review and approve change controls impacting facilities, utilities, equipment, systems, and processes.
· Ensure changes are appropriately assessed for impact, risk, and regulatory compliance
· Support operational and inspection readiness for Health Agency inspections.
· Support quality processes and systems across the product lifecycle, including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
· Participate in or lead quality risk analysis/assessments.
· Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
· Lead and participate in deviation investigations as necessary.
· Promote a quality mindset and quality excellence approach to all activities.
· Promote a safety mindset and focus on safety for all operational activities.
· Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
· Participate in and/or lead health authority (primarily FDA and E.U.) agency inspections at the site.
Basic Qualifications and Capabilities:
· Bachelor’s degree in a scientific discipline with a minimum of 10 years of Quality/cGMP experience. Experience in facility, utilities, and equipment qualification, computer and process validation, calibration, and maintenance programs for the manufacture of sterile injectable medications.
· Knowledge and experience in translating FDA and European Medicines Agency (EMA) requirements and guidance into operational success, including but not limited to Annex 1 requirements for sterile injectable medications, 21CFR Part 11, Electronic Records and Signatures, and data integrity are required.
· Technical expertise in sterile pharmaceutical isolator technology, combination products, and medical devices is highly desirable.
· Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
· Quality management experience across the product development and commercialization lifecycle, including change management and associated implementation strategies.
· Participation and leading activities to support regulatory agency inspections (FDA/EMA) are required.
· Excellent interpersonal and written communication skills and experience using various software/electronic applications are required.
· Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
· Ability to collaborate and manage conflict in a fast-paced environment.
· Self-motivated, flexible, and able to work in a small, start-up, and dynamic environment.
· Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
Physical Demands and Work Environment:
The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable
