Quality Compliance Manager

Manager, Laboratory Quality & Compliance, is responsible for maintaining the quality and compliance of laboratory operations through the creation, refinement, or application of the Quality System. This includes managing investigations, deviations, CAPAs, change controls, risk analysis, employee training, SOP development, and audits. The Manager will continuously monitor compliance with regulations and internal standards, and ensure alignment with industry best practices, where applicable.

Essential Duties and Responsibilities:

• Author, revise, review, and/or approve SOPs, Client Operating Protocols (COP), Policies, training material, or other controlled documentation.
• Author, review, and/or approve GMP and non-GMP records.
• Author, drive implementation, and check the effectiveness of CAPAs. Track open CAPAs, ensuring timely completion, and/or requesting extensions as applicable.
• Author, review, and/or approve deviation and investigation reports related to out of specification results or quality system failures, perform Root Cause Analysis (RCA), perform required Client notifications, and evaluate impact to SISPQ. Track open deviations, ensuring timely completion, and/or requesting extensions as applicable.
• Provide Quality oversight of operation activities which may include:
• Coordinate and provide appropriate QA coverage for routine operations.
• Monitor incoming or outgoing products and materials for errors, interfacing with Clients, and working to resolve non-conformances.
• Provide general Quality duties in an inventory system (status changes, expiration date changes, approving new items, etc.).
• Perform/Review internal material releases on labels, drug products, etc.
• Review and/or approve batch record/protocol.
• Provide Quality Assurance oversight of a stability program, including protocols, studies, metrics, as well as routine review of the data.
• Review and/or approve Certificates of Analysis or similar documentation for internal and external Clients.
• Provide Quality Assurance support for ongoing maintenance of analytical methods and specifications.
• Review and/or approve laboratory documents, including testing methods, procedures, change controls, method transfer/validation protocols, analytical standards, stability data, and associated reports.
• Provide quality oversight over internal/external validation and calibration activities and documentation in compliance with the Validation Master Plan, SOPs, and applicable regulations.
• Oversee the supplier qualification program. This includes but is not limited to:
• Tracking the status of all supplier qualifications and ensuring requalification’s are performed on time.
• Performing paper audits of all necessary suppliers and ensuring all necessary records are on file.
• Perform the physical audits of suppliers as applicable.
• Maintain federal/state licenses and related documents required by various entities for business. Ensure the timely submission of license renewals and report status.
• Support and/or host internal, Client, and regulatory audits/inspections.
• Develop and report on quality metrics.
• Provide training to staff on quality-related procedures and standards to ensure a consistent understanding of quality requirements.
• Train new Quality Assurance staff.
• Develop and track quality metrics.
• Periodically carry on-call phone and respond to after-hours alarm situations.
• Additional duties as assigned by manager.

Competencies:

• Self-motivated with minimal need for supervision.
• Ability to multi-task and manage time effectively under pressure.
• Effective time management.
• Excellent attendance and punctuality.
• Detail-oriented with strong organizational skills.
• In-depth knowledge of GMP regulations and reporting requirements.
• Commitment to continuous improvement and adaptability to change.
• Understanding of job functions and their relation to other roles within the organization.
• Excellent verbal and written communication skills, with the ability to develop rapport at all organizational levels.
• Results-driven with personal initiative and perseverance.
• Excellent teamwork and collaboration skills.

Education/Experience:

Required: BA or BS in a science/technical field and five (5) years of QA/QC experience in a pharmaceutical, biotech, medical device, or other FDA-regulated industry. Including at least two (2) years of QA/QC laboratory experience.

Location: Columbus, IN

Department: Quality Assurance

Schedule: Full Time, On-Site

Education: BS or BA Degree in Science/Technical Field (Required)

Experience: 5 Years of QA/QC in a Pharmaceutical, Biotech, Medical Device, or other FDA-Regulated Industry.