To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02523

About our client Our client is a pharmaceutical company and works to develop, manufacture and market pharmaceutical therapies indicated for diseases/medical conditions requiring specialized treatment. The company’s prescription drugs are marketed both nationally and internationally. It caters to therapeutic categories of antiviral and anti-fungal agents. Position Location Director of Quality Assurance Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Evaluate current written procedures and assist in drafting and implementing new procedures 2) Review and approve executed batch production and control records, and packaging records 3) Evaluate internal and external contract facilities for compliance with the appropriate GxP requirements and regulatory expectations 4) Participate in external and internal work groups regarding GxP and other regulatory or industry requirements for commercial production 5) Review and comment on SOPs for consistency with GxP and regulatory guidance requirements 6) Evaluate internal and external documentation, including quality investigations and protocols 7) Evaluate API, excipients and packaging material vendors 8) Audit and self-inspect internal functional areas 9) Host customer audits and follow-up audit reports 10) Ensure the following up of requisite compliance programs, including change control and CAPA management 11) Prepare regulatory submissions and responses to regulatory agencies, including Annual Product Reviews 12) Oversee final disposition of commercial product 13) Act as a primary contact for inspections of commercial products and facilities by regulatory authorities, clients and partners 14) Cooperate with Regulatory Affairs management and staff in developing mutually beneficial systems and procedures that improve the overall quality compliance 15) Oversee Annual Product Report 16) Provide or assist in procuring appropriate training to the staff and management in the areas of regulatory compliance and quality management 17) Oversee training program 18) Participate in national and internal QA professional organizations 19) Keep abreast of changes and developments and demonstrate commitment to leadership in the research QA profession Requirements 1) Bachelor of Science 2) 8+ years of experience in pharmaceuticals 3) Minimum 5 years of hands-on experience in quality assurance 4) Familiarity with manufacturing facilities/sites and extensive experience in auditing such facilities/sites 5) Membership and certification in application professional organizations preferred 6) Ability to perform with minimal supervision 7) Strong decision-making abilities and a sense of when to involve management in the decision process 8) Ability to interact with diverse departments to initiate and complete projects in a timely manner 9) Good management skills to manage and supervise staff or consultants 10) Excellent organizational and communication skills 11) Willingness to travel – both domestic and internationally