Associate Director QA Validation

THIS POSITION WILL REQUIRE 5 DAYS ONSITE IN VIRGINIA.

Job Description:

This position is at a new fill finish facility dedicated to the manufacture and supply of essential generic sterile and biosimilar injectable medications.

Responsibilities of the position include establishing and maintaining quality systems and compliance oversight to ensure the validation/qualification and operation of processes, facility, equipment, and computer systems meet cGMP requirements at the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

The role is essential to assure the site validation and qualification programs comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines. Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of validation, qualification and ongoing verification and operational activities of facility, utilities, process, equipment, instrumentation meet or exceed Health Agency requirements.

Essential Duties and Responsibilities:

• Provide leadership, direction, and support to the people within Quality Assurance Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Establish and maintain the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes by working across functions.
• Ensure the Quality oversight and review of validation and qualification activities and documentation for the site is performed including assurance that the appropriate resources, materials, and documentation are utilised, and that work is performed in a compliant and controlled manner.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
• Ensure implementation and quality oversight related to the overall compliance of the facility, utilities, equipment, and manufacturing processes.
• Lead operational and inspection readiness for Health Agency inspections.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
• Provide quality oversight for calibration and maintenance programs and ensure they are developed and run-in accordance with GMP regulation.
• Participate or lead in quality risk analysis/assessments.
• Participate or lead the assessment, qualification, and approval of suppliers.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Lead and participate in deviation investigations as necessary.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
• Participate in and/or lead health authority (primarily FDA and E.U.) agency inspections at the site.
• Travel (up to 10%) may be required.

Qualifications:

• Bachelor’s degree in a scientific discipline with a minimum of 14 years Quality/CGMP management experience including 7 years in a supervisory role in the pharmaceutical industry.
• Experience in facility, utilities and equipment qualification, computer and process validation and calibration and maintenance programs for the manufacture of sterile injectable medications.
• Knowledge and experience in translating FDA and European Medicines Agency (EMA) requirements and guidance into operations success including but not limited to Annex 1 requirements for sterile injectable medications, 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
• Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Quality management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
• Participation and leading activities to support regulatory agency inspections (FDA/EMA) required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.