Director of QA

Director of QA Profile:

Direct and oversee the department and on-going maintenance of this CDMO’s Manufacturing Quality Assurance Operations to ensure cGMP compliance with US and international regulations.

This company has more than 360,000 square feet of operating space with over 70 manufacturing suites include containment areas for handling high potency compounds and hormones, dedicated manufacturing suites for oral products (e.g., soft gels) and injectables (e.g., vials, syringes, cartridges), a formulation development center, and analytical and micro laboratories.

Director of QA Key Activities

The successful Director of QA will be responsible for the following tasks:

• Interact with management and department heads as appropriate to ensure compliance requirements are understood, adhered to, and met.
• Communicate to the executive team deficiencies in quality and compliance standards and work with internal staff, suppliers, and clients on corrective and preventative actions.
• Ensure inspection readiness of all company GMP manufacturing facilities.
• Host and/or manage company regulatory inspections, including managing inspection logistics, providing strategic direction to staff, final approval in inspection responses and tracking corrective actions to closure.
• Review and evaluate effectiveness of actions identified in Operations.
• Provide oversight for Manufacturing operations including QA oversight of sterile product manufacturing and related systems.
• Work with department heads as appropriate to plan and direct resource allocations, work activities, and monitor progress such that corrective and preventative actions are accomplished efficiently, completely and within established time frames.
• Provide direction, development, and leadership of staff. Establish realistic goals and objectives. Plan and direct work activities and monitor progress such that goals and objectives are accomplished efficiently, completely and within established timeframes.
• Champion and advocate product quality and cGMP compliance throughout the company.
• To support or contribute to the preparation, review, and approval of QA-related documentation in accordance with approved SOPs including batch documentation, protocols, and SOPs.
• To perform or assist in general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, generation of technical reports, and reporting of quality metrics.
• To ensure that appropriate quality standards are applied in accordance with regulatory, pharmacopoeias and company requirements.
• To review quality system documents to ensure that they comply with relevant SOPs, are GMP compliant and meet regulatory requirements.
• To drive the revision and approval of QA reviewed documents.
• To escalate compliance issues appropriately when discovered.
• To participate in meetings to report on, contribute to and/or resolve quality related matters.
• To represent QA in various internal/external meetings. To provide QA related expertise.
• Perform additional duties, as assigned.

Director of QA Specification

The following will be required of the Director of QA:

• At least ten years’ experience in a cGMP regulated environment with direct experience overseeing aseptic manufacturing operations.
• Strong knowledge and understanding of the U.S and international regulations or guidelines applicable to both clinical and commercial manufacturing.
• Experience with internal and external audit practices and requirements
• Must be able to comprehend and follow all applicable SOPs.
• Excellent technical writing skills and experience in writing and maintaining cGMP documentation.
• Ability to analyze data/information to assess and resolve problems or differing complexity.
• Knowledge / Experience with electronic Quality Management Systems such as MasterControl
• Understands current federal, local, and international regulations regarding the production, testing and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Familiarity with Microsoft programs, such as Word, Excel, PowerPoint, Access, Project, etc.

Director of QA Personal Skills and Qualifications

The successful Director of QA will possess the following:

• Bachelor’s Degree in the Life Sciences is preferred, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Ability to always portray an appropriate level of integrity and professionalism.
• Ability to communicate effectively with management, staff, regulators, and client representatives, in both written and verbal forms.
• Ability to complete tasks accurately and according to established timelines.
• Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
• Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Ability to work closely with a diverse customer and employee base (internally and externally).
• Ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

To Apply for the position of Director of QA, or to find out what other opportunities we can offer in the life sciences sector, please either use the form on the right or contact us on  +44 (0) 1252 938 100 or ContactUs@centrelineresourcing.com at Centreline Resourcing. You can also find our currently advertised jobs at https://centrelineresourcing.com/jobs/ or check out our LinkedIn page at https://www.linkedin.com/company/centreline-resourcing/