Mgr Quality Control

Role Summary

Lead and manage Quality Control Laboratory operations for the commercial production schedule at an Oral Solid Dose Biologic Vaccine manufacturing site. Oversee planning and scheduling of raw materials, in-process and finished products, method transfers, and related projects, and conduct or coordinate laboratory investigations and projects. Develop and mentor QC analysts and technicians to ensure safety, regulatory compliance and cGMP adherence, and collaborate with internal and external partners to meet timelines and quality objectives.

Responsibilities

• Responsible for management and development of direct and indirect reports.
• Responsible for overseeing projects carried out by senior direct reports.
• Responsible for assisting and coordinating the initial and on-going training of analysts and technicians with regard to safety, regulatory and cGMP issues associated with working in the QC Laboratory.
• Responsible for prioritizing and coordinating testing of raw material, in-process, bulk product, packaged finished product, stability samples, micro samples, and/or water samples for analysts, as needed to support manufacturing. Assist in the checking/auditing of raw data and various logs generated by analysts.
• Responsible for liaising between QC functional groups (Finished Product, Raw Materials, Sampling, etc) and internal and external partners to set priorities and schedules to meet timelines.
• Responsible for generating a rolling daily/weekly Master Planning Schedule for Quality Control Lab based off the priority of Operations.
• Responsible for compiling QC Metrics (internal and corporate) and communicating within and above site as required.
• Responsible for conducting or coordinating the creation of Incident, Deviation and Out of Specification Investigation and Out of Trend Investigation reports.
• Responsible for assisting in maintenance of equipment and computerized systems as needed. This includes overseeing maintenance, qualification and GMP status of laboratory instruments needed for sample analysis or other analytical work.
• Responsible for performing complex revisions to Standard Operating Procedures, Test Methods, and Specifications.
• Responsible for coordinating and designing activities associated with the stability program including sample management activities and data analyses and performing statistical analyses.
• Responsible for project management activities for certain projects related to capacity, efficiency, and utilization.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, cGMPs, SOPs and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Qualifications

• Bachelor's degree in chemistry or related scientific discipline or equivalent, with a minimum of 5 years relevant progressive experience in a Quality Control laboratory environment.
• Minimum of 2 years of management experience in an environment supporting a production operation.
• In-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Advanced understanding of the principles of analytical chemistry and/or microbiology as it applies to the responsible area.
• Advanced abilities related to technical writing and documentation activities; able to design and document a process with little to no oversight.
• Advanced understanding of the fundamental principles and theory behind analytical techniques, including, but not limited to GC, FTIR, NEAR-IR, UV spectroscopy and TOC.
• Experience with OSD, Biologics, and/or Vaccines is advantageous.

Education

• Bachelor’s degree in chemistry or related scientific discipline or equivalent.

Skills

• Computer proficiency with MS Office products, Learning Management Systems (LMS), ERP systems such as SAP/Oracle and quality/manufacturing systems such as Trackwise/Veeva and Qdocs.
• Excellent written and oral communication skills.
• Self-directed with ability to organize and prioritize work.
• Ability to identify developmental needs of others and provide coaching or mentoring to improve knowledge or skills.
• Ability to motivate, influence and lead others with or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Ability to demonstrate sound judgment and decision making.
• Ability to analyze information and create metrics relevant to business objectives.