Associate Director, Quality Assurance

at  MedPharm

REQUIRED QUALIFICATIONS AND SKILLS:

• Bachelor’s degree required
• 7 or more years relevant experience
• Thorough knowledge and understanding of applicable GMP regulations for UK, EU and US activities as detailed in EU directives 21CFR and ICH guidelines related to pharmaceutical industry
• Knowledge of scientific calculations and SI units and ability to calculate relevant statistical data analysis (e.g. linearity, concentration, assay content, %CV)
• IT literate and proficiency in MS Office (super-user on applicable equipment and software)
• Experience working with a GxP or equivalent quality management system and equipment validation
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JOB PURPOSE:

The primary responsibility of the Associate Director of Quality is to oversee and manage the QA Unit activities to ensure that topicals drug products developed, tested and manufactured meet quality and compliance standards. The incumbent is critical in maintaining and continuously improving our Quality Management System (QMS) in alignment and compliance with SOP’s and applicable GxP’s with consideration to the latest relevant regulatory guidelines. The Associate Director of Quality will work closely with the VP of QA to ensure that policies are developed and implemented and maintain effective communication and partnership with all departments across the organization

SUMMARY OF KEY RESPONSIBILITIES:

This position has full management responsibilities for a department, unit, and/or subdivision including, selection, training, guidance, and performance

• Established and enforce procedures and practices according to industry standards and in compliance with Good Manufacturing Practices (GMP) EC Guide Volume IV (Current) as defined in ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007’ published by the MHRA and Directives 2001/20/EC and 2003/94/EC, UK SI 1999 No. 3106: The Good Laboratory Practice, US FDA 21 CFR §§ 210 and 211, ISO standards (i.e. ISO 9001, 13485), Sarbanes Oxley and 21 CFR 820 and 320.
• Drive continuous improvement initiatives to enhance product quality, reduce risk, and increase efficiency.
• Management of the QA team to maximize individual and team performance. Ensure the department is resourced appropriately and that staff are trained, developed and appraised in line with company procedures.
• Management of the Document control program and ensure the issuance of controlled documents for GxP activities. Create and maintain the quality programs documentation by writing and updating quality assurance procedures, as needed. Review and approval of quality related documents, including but not limited to, study protocols and reports, manufacturing records, specifications and test method, deviations, validation reports, laboratory data and other relevant documents as needed.
• Ensure all products meet quality standards and specifications before release.
• Management of QMS records including deviations, Corrective and Preventive Action (CAPA) plans and change controls related to process / product deviations, material testing, and Out-of-Specification events.
• Responsible for managing all internal and external audit programs, including but not limited to supply chain audits, process audits and as a Lead Auditor managing teams of auditors. This includes establishing the compliance requirements, collecting objective evidence, and writing audit reports to ensure the quality management system is operating effectively.
• Track, trend and report an appropriate range of key Quality performance indicators and communicate to Site leadership and executive management. Use data and quality metrics to identify areas for improvement and implement corrective actions.
• Manage a Quality Risk Management program for the company ensuring that significant risks are identified and reported appropriately, and that mitigation and contingency are established.
• Maintains knowledge of current regulatory requirements, industry trends and best practices and ensures compliance.
• Escalates any quality issues immediately to Executive Management as appropriate management.
• Lead preparation for and management of regulatory inspections and client audits.
• Ensure suitable management of archiving processes (either by directly acting as archivist/deputy archivist or suitably delegating within the QA team) both onsite and in collaboration with MedPharm’s contract archiving site.
• Manage the department’s budget and finances.
• Liaise with departmental management to ensure suitable training programs are in place for staff engaged in GxP activities
• To perform any other tasks at the request of MedPharm senior management appropriate to the job function.
• To maintain your personal training record.

To perform the job successfully, an individual should demonstrate the following:

• Quality: Applies feedback to improve performance; Demonstrates accuracy and thoroughness; Displays commitment to excellence; Looks for ways to improve and promote quality; Monitors own work to ensure quality
• Team Leadership: Acknowledges team accomplishments; Defines team roles and responsibilities; Ensures progress toward goals; Fosters team cooperation; Supports group problem solving
• Communication: Exhibits good listening and comprehension; Expresses ideas and thoughts in written form; Expresses ideas and thoughts verbally; Keeps others adequately informed; Selects and uses appropriate communication methods
• Problem Solving: Develops alternative solutions; Gathers and analyses information skilfully; Identifies problems in a timely manner; Resolves problems in early stages; Works well in group problem solving situations
• Judgment: Displays willingness to make decisions; Exhibits sound and accurate judgment; Includes appropriate people in decision making process; Makes timely decisions; Supports and explains reasoning for decisions
• Planning & Organization: Integrates changes smoothly; Plans for additional resources; Prioritizes and plans work activities; Sets goals and objectives; Uses time efficiently; Works in an organized manner
• Read, analyze and interpret business, professional, technical or governmental documents. Write reports, business correspondence and procedure manuals. Effectively present information and respond to questions from managers, customers and the public
• Able to carry out complex tasks and quality reviews without supervision, drawing on experience to make decisions.
• Clear and precise verbal and written communicator.
• Thorough autonomous planning and organising skills.
• Competent to design and train in most procedures