Director, Quality Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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).