Supervisor, Quality Program Management

About the role

The Quality Program Management Supervisor oversees and guides the QA batch record review and product disposition team. This role supports client quality relationships, ensures timely review and disposition of batch records, and coordinates shipments with the warehouse.

Responsibilities

• Support client Quality relationships through effective communication and timely deliverables
• Review and assist in the disposition of executed Batch Records (Clinical, Commercial, & Media Fills)
• Collaborate with cross-functional teams to address review comments
• Maintain the record review planner to track and monitor the stages of the batch disposition process
• Aid in monitoring and improving batch record review and disposition cycle times
• Track metrics for the review and disposition process and provide input for monthly performance analysis
• Oversee Disposition timelines and support client calls related to Disposition schedules and delays
• Coordinate shipments with the Warehouse (including Q Ships & Release Shipments)
• Participate in critical DEV review meetings and provide quality input as needed
• Contribute to the preparation and presentation of weekly and monthly metrics for leadership
• Assist in developing batch record review training materials for Quality and Production teams
• Review and provide input on SOPs related to the functional area
• Identify process improvements and assist in their implementation
• Provide support in other QA areas as assigned by QA Management

Requirements

• Bachelor’s degree in Science, Chemistry, Biology or related field of study
• Minimum of three (3) years in Quality Assurance or Regulatory Compliance Management
• Minimum of two (2) years in a leadership role
• Minimum of three (3) years in an aseptic/sterile product facility, preferred
• Knowledge in current regulations (21CFR, Annex 1 etc), preferred

Qualifications

• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages
• Strong grasp of algebraic and geometric principles
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Effective presentation skills, enabling successful presentations to groups of managers, clients, customers, and the general public
• Reasoning ability to interpret documents and execute tasks
• Computer skills to utilize diverse software tools to streamline the organization's daily functions
• Adaptability to work in a sterile environment, including aseptic gowning, use of personal protective equipment, and adherence to safety protocols
• Physical demands to sit, stand, reach, lift up to 25 pounds occasionally, and work in a variety of environments

Skills

• Leadership and mentoring skills
• Business acumen
• Collaborative and positive work environment
• Change champion
• Attention to detail

Benefits

• Generous benefit options
• Paid training, vacation, and holidays
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Full-time position with flexible scheduling to accommodate the needs of the team and the company.