As the Quality Systems Manager, you will lead and direct the Quality Systems group, supporting the Vice President of Quality and Regulatory Compliance on all quality, regulatory, and compliance matters. This role is integral in ensuring cGMP compliance during audits conducted by governmental agencies and customers. You will also ensure that all work adheres to regulatory/cGMP guidelines as well as Bell International Laboratories’ standards and policies.

Responsibilities

• Oversee Change Control process and provide Quality Guidance to the organization
• Lead the development of SOPs, oversee the review and approval of Deviations and CAPA, and provide guidance. Manage and oversee the entire Deviation and CAPA programs.
• Manages daily operations of the Quality Control Technicians
• Exercises responsibility for associate training and development and motivating supervised associates.
• Manage Recall/Mock Recall Process
• Lead Quality Management Review Meetings and Action Items
• Contribute to the development and justification of the annual Quality Assurance budget. Participate in planning and forecasting, and provide analysis and monitoring to support Bell International Labs
• Manage, track, and meet or exceed annual budget requirements
• Reviews and approves direct reports timecards and PTO requests
• Performs other duties and assignments as required.

Requirements

Required Skills/Abilities

• High level of cGMP compliance understanding and ability to effectively communicate with FDA, other regulatory agencies, and customers
• High level of Risk Assessment knowledge relating to recalls, deviations and non-compliance events
• Excellent understanding of pharmaceutical manufacturing and packaging
• Excellent leadership and coaching skills
• Proven ability to collaborate with other departments
• Proven track record of regulatory compliance
• Excellent writing skills and strong interpersonal skills required
• Proficient in Microsoft Office (Word, PowerPoint and Excel)

Required Education and Experience

• Bachelors degree required, preferably in Life Sciences, Chemistry, Medical technology or equivalent pharmaceutical experience
• 5 + years in Pharmaceutical or Medical Device Quality Systems experience

Additional Information

EEO Statement

Bell International Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.