What are the responsibilities and job description for the Senior Manager, Quality Compliance position at Glenmark Pharmaceuticals?
Position Summary
Financial
Education
- Under the direction of the Senior Director of Quality, the Senior Manager, Quality Compliance is responsible for implementing and managing the systems related to GxP compliance which includes, but is not limited to, the following systems: Supplier Management, Internal and External Audits, Electronic Quality Management Systems, Customer Complaints, Adverse Events, Product Recall, Field Alerts and Regulatory Surveillance. Support audits / inspection processes, including, but not limited to: governmental, regulatory, Corporate or vendor audits and audit readiness related activities. This position is located in Monroe, NC and requires approximately 10-15% travel.
Financial
- 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 compliance system controls to ensure state of compliance and no critical and major market complaints, which includes, but is not limited to, the following systems: Supplier Management, Internal and External Audits, Electronic Quality Management Systems, Customer Complaints, Adverse Events, Product Recall, Field Alerts and Regulatory Surveillance.
- Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.
- Oversee quality systems to verify compliance with applicable internal procedures and regulatory requirements.
- Manage the supplier quality program in accordance with regulatory and site procedural requirements.
- Oversee and perform (as required) internal and supplier audits.
- Participate in Regulatory Surveillance program implemented through CQA.
- Preparing responses to internal and external audits and tracking actions for timely closure.
- Coordinate activities pertains to Product Recall and Field Alerts.
- Provide support for the Annual Product Review of marketed products.
- Coordinate for effective and timely closure of audit CAPA with Vendors/CTLs.
- Serve as site representative for Quality Compliance during 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.
- Handling of market complaints for investigation and trending.
- Establish, revise, review and continuously improve procedures for the Monroe site Quality Compliance.
- Lead and develop quality compliance personnel and drive quality culture for the site.
- Establish Key Performance Indicating (KPIs) for the functional area and ensure systems are operating within target.
Education
- Minimum Bachelor’s degree in scientific discipline or closely related technical field of study
- A minimum of 10 years of Quality Assurance experience in the Pharmaceutical, Biotech or medical device industry (or related industry)
- Advanced degrees may be used to reduce required experience
- 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 analyse 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, TrackWise, 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
- Quality certifications or training a plus
