- Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
- Maintain quality system controls to ensure state of compliance and no critical and major market complaints.
- Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.
- Take appropriate steps to reduce wastages and losses in the process and build improved efficiency.
- Perform internal and supplier audits to verify compliance with applicable internal procedures and regulatory requirements.
- Perform supplier audits for Active Pharmaceutical Ingredients (API), raw materials, packaging materials, process consumables, contract laboratories, software suppliers and any others, as required.
- Manage Supplier Corrective Action/Supplier Scorecard program. Follow up on corrective and preventative actions with suppliers.
- Establish and maintain supplier Quality Agreements, supplier audit files and approved supplier list for site.
- Perform trending to ensure shifts are detected and corrected.
- Develop audit plan and schedule and perform all audits per schedule.
- Manage audits utilizing manual or electronic system.
- Write audit reports and issue audit follow-up documents in a timely manner. Track open observations and Corrective and Preventative Actions (CAPAs) to closure.
- Support regulatory inspections and corporate audits.
- Determine and document decisions on supplier qualification status, escalate critical findings to Senior Management.
- Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures.
- Establish, revise, review and continuously improve procedures for the internal audit and supplier management programs.
- Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.
Under the direction of the Senior Manager of Quality Systems and Compliance, the Compliance Auditor is responsible for leading the internal audit program and supplier management. This individual is responsible for planning, conducting and closing all internal and supplier audits, as well as representing the site as the primary contact for all audit-related communication with suppliers. This position requires approximately 25-50% travel.
- Minimum Bachelor’s degree in scientific discipline or closely related technical field of study
- A minimum of 10 years of experience in the Pharmaceutical, Biotech or medical device industry (or related industry)
- A minimum of 2 years of Quality Assurance experience
- Advanced degrees may be used to reduce required experience
- Experience executing internal and supplier audits
- Strong understanding of FDA requirements, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
- Must be proactive, results oriented, with a strong attention to detail
- Self-starter with great work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment
- Strong organizational, analytical, troubleshooting and problem-solving skills
- Ability to analyze details and perform structured decision-making on a daily basis
- Must be able to read, write, and speak English
- Excellent verbal and written communication/documentation skills
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
- Knowledge of MasterControl, LIMS (Laboratory Information Management System), SAP (Systems, Applications & Products in Data Processing) and/or other electronic Quality Management Systems is a plus
- The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required, as well as the ability to design, navigate and advance a Quality Systems program.
- CQA or equivalent desired, but not required