Quality​/Compliance Manager

Quality Manager / Quality/Compliance Manager

Must have a strong background in quality assurance requirements for a Biotech/Pharmaceutical Manufacturing facility from an operations, facilities, and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities team, and its subcontractors, performs in full accordance with contractual, procedural and regulatory requirements within a cGMP culture environment. Must have a solid understanding of cGMPs as they relate to maintenance and repairs of equipment, facilities and utilities.

An engineering background, or equivalent experience, would be desired. Requires ability to prepare and manage documents, investigations, CAPAs, audits, change control documentation, and training materials for use by the facilities team.

Expected to interface with the site’s quality unit to ensure through the established Quality Agreement all applicable regulations and procedures are followed, and that the work performed by the team is documented and recorded properly. Responsible for sustaining a quality program and culture at a state-of-the-art cGMP manufacturing facility. Must have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity.

A background and understanding of FDA regulations including 210 CFR Part 210 and 211 would be desired but not required.

Commitment to quality assurance and willingness to help develop a quality-first culture on the site. Self‑motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision. Strong oral and written communication skills and ability to communicate and gain the trust of all levels of management and interface with a diverse customer base including technical and non‑technical personnel.

• Perform investigations of significant event deviations, root cause analysis (RCA), impact assessment, and trend evaluations.
• Lead assigned Corrective and Preventive Actions (CAPAs).
• Develop and review trend analysis reports related to the facility scope of work.
• Manage the GxP Contractors compliance program (e.g., qualification, agreements, audits, performances, etc.).
• Oversee the quality/compliance program for facility support systems including maintenance of equipment, environmental monitoring systems, HVAC, utilities, and site support services such as calibration, janitorial cleaning, pest control, garments, and shipping/receiving activities.
• Manage the site’s self‑assessment program and corresponding corrective actions.
• Maintain all infrastructure and compliance documentation for the facility to meet regulatory compliance with contractual, procedural, federal, state or local law requirements.
• Read and understand the applicable Service Level Agreements, standard operating procedures to achieve Key Performance Indicators and score favorably on client satisfaction surveys.
• Support and oversee the team’s training compliance program and review of corresponding training curricula.
• Ensure appropriate follow up with customers.
• Seek to continuously improve quality processes, systems and overall customer satisfaction.
• Provide direction/information to vendors, facilities staff and service providers to ensure quality assurance expectations are communicated and followed.
• Perform additional job duties as requested, including analysis and reporting.
• Ensure adherence to ISO 9001:2015 standard requirements.

• BA/BS in Science is preferred, or equivalent quality engineering and production/facility operations experience.
• Have a minimum of three to five (5+) years of experience in Pharma, Biotech or similar life science sector governed by GMP regulations, systems and processes working in a Quality Assurance role.
• Knowledge of Quality Engineering techniques such as investigations, RCAs, CAPAs, audit programs, vendor qualification, and quality management systems.
• EIT or PE is a plus.
• Strong working knowledge of computer applications, including MS Office.
• Working knowledge of Quality System such as Track Wise, Success Factors, Infinity, etc.
• Demonstrated verbal and written communication skills.
• Proven record of excellent internal and external customer service.