Role Summary:
Develop, direct and lead Quality Oversight of Pharmaceutical and Combination Products (Drug/Device) manufacturing production activities for St. Louis Operations in the following areas: current GMPs, Regulatory/CMC, deviation investigations, corrective and preventative actions, batch record review, environmental control program, regulatory inspections and audits, change management, and contemporary product and process validation.
Supports the development, implementation and monitoring of Quality and Regulatory Compliance strategies for combination products at the Bridgeton Manufacturing site. Ensures the inspectional readiness of the site at all times and compliance with all applicable regulations within the scope of the manufacturing site’s activities.
This position leads a team of managers and individual contributor direct reports with a wide range of quality compliance responsibilities within Quality Assurance.
ROLE RESPONSIBILITIES:

• Lead and engage with cross functional teams as needed to support continuous improvement activities.
• Conducts Quality Notification Reports activities and Notice to Management activities as QO Leader designee.
• Develop, implement and execute procedures to assure compliance with regulatory requirements and internal policies.
• Coordinate record issuance, auditing, approval and recordkeeping activities for batching of formulation and filling.
• Provide availability for off-shift remote coverage for Quality decisions
• Partner with Quality Systems and Production to develop and assure job function curricula are in place for all Manufacturing area, Quality Operations personnel.
• Ensure documentation practices and systems are in place in compliance cGMPs and standard operating procedures.
• Work with management teams to ensure programs are in place to support and measure technical skill development.
• Work with site leadership to analyze business needs and meet departmental budget.
• Work with site management to continuously improve technical training effectiveness and efficiency.
• Supports operational excellence and site transformational initiatives. Facilitates M1 investigations when required.
• Support process to hire, develop, coach, reward and monitor training and communication staff members. Establish succession plans as needed for critical positions.
• Set and implement objectives and development plans for direct staff as well as indirect departmental and on-the-job training.
• Lead regulatory inspections and audits, respond to requests and findings, and track commitments for Manufacturing operations.
• Support communication process improvements throughout the site and enable replication of good practices between sites.
• Support production of site-wide meetings and special events and visits.

BASIC QUALIFICATIONS:

• Minimum of a Bachelor of Science Degree in Microbiology, Biology, Chemistry or related Technical Physical Science. Master Degree in related discipline preferred.
• Minimum of five years supervisory/managerial experience in a Quality organization.

Technical Skills:

• Minimum of seven years progressive experience in GMP Manufacturing environment. Two or more years of experience in Pharmaceutical, Combination device or Medical device and Aseptic manufacturing environment. Knowledgeable of current trends in applicable Manufacturing standards and regulatory compliance requirements for Medical Device or combination device manufacturing (FDA, EU) preferred.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers.
• Ability to define problems, collect data, establish facts, and draw valid conclusion; interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract or concrete variables. Ability to gather and analyze information skillfully and present in many forms.
• Should have the ability to perform advanced mathematical concepts such as exponents, logarithms, quadratic equations (as needed), and apply mathematical operations to such tasks such as frequency distribution, CpK, determination of test reliability.