Work Schedule

Environmental Conditions

Job Description

•             Provide leadership to assigned staff by performing the following: leading organizational change; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff is motivated to do their best.

•             Ensure the successful day-to-day operations of Quality Assurance - Operations departments including the Product Quality Leads, QA on the Floor, and Batch Disposition teams.

•             Facilitate the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements.

•             Establish meaningful goals and metrics for groups in conjunction with the Site Head of Quality.

•             Work with customers to ensure clear and open communication is maintained when intermediate levels of partner concern are required by the QA staff.

•             Present priorities and distribute work assignments. Ensure that all work performed by staff is performed safely, with quality, and in a timely, manner.

•             Lead and ensure group participation in continuous improvement projects throughout the group and the facility/operational portions of the organization.

•             Lead, run and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations.

Qualifications:

•             Bachelor’s degree in a scientific subject area

•             10+ years in a GMP environment

•             4+ years of prior successful experience in a Manager role is required.

•             Performing in a contract manufacturing environment or leading contract businesses

•             Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other international guidelines to all aspects of the position.

•             Technical knowledge of (bio)pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable

•             Strong interpersonal and communications skills; written and oral, and a validated ability to make key decisions.

•             Proficient with computer (MS Office) and internet skills. Understanding of controlled documentation and data systems.

•             Continuous improvement mentality.

•             Assurance of quality throughout all operations within the facility. The ability to constructively work with colleagues when a Quality concern conflicts with short-term business desires to conclude the issue at hand to the best business advantage (both short- and long-term) without sacrificing the quality of work or the Quality Culture at the facility.

•            Ability to build and maintain highly functioning teams, cohesive, targeting for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.

•             Actively takes the lead in ensuring GMP compliance for the company. Sets strategy in investigations and CAPAs.

•             Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).