Mantell Associates is partnered with a Pharmaceutical organisation in their search for a Site Quality Head to join their senior leadership team and build, lead and execute a quality strategy. You will report to the VP & Group Quality Head.

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Site Quality Head - Responsibilities:

• Responsible for site quality management systems, GxP activities, and batch disposition

• Act as key member of the site leadership team and group quality leadership team

• Cultivate a sustainable "Quality Always" mindset / culture throughout the organization

• Lead the Quality Assurance team (operational quality, quality systems, and compliance, validation) and Quality Control Team

• Responsible for staff training and developing the Quality organization

• Oversee all GxP activities (all activities associated with manufacturing, testing and release, facility, and utilities) at the site and ensure current Good Manufacturing Practices (cGMP) are being followed

• Responsible for ensuring Quality systems comply with most current regulatory requirements in the markets in which the company operates not limited to US FDA, EU, ANVISA, PIC/S, and TFDA

• Responsible for continuous improvement of these quality systems

• Oversee quality audits including external audits and internal audits as well as audit responses. Host customer/regulatory audits for the site

• Interface with Quality Personnel, cross functional personnel and external parties on quality issues and queries

• Responsible for managing batch disposition, recalls, and complaints (including product quality complaints and adverse events)

• Quality oversight of new product introduction, technology transfer, and support product registrations

• Quality oversight of management of suppliers and third parties (e.g., contract manufacturing, contract laboratories). Responsible for ensuring these suppliers and third parties meet the required quality requirements

• Responsible for managing the Quality department budget, headcount, and capital expenditure

• Provides quality oversight for Good Distribution Practices for the commercial

• Provides quality management for the in-licensing products to Taiwan market.

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Site Quality Head - Requirements:

• Graduate in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology from reputable university

• Proven track record of non-sterile OSD quality management for highly regulated markets with at least 10 to 15 years in reputable Global Pharmaceutical companies

• Preference to have proven exposure and track record of hosting / managing of regulatory inspections for USFDA, EMA etc

• Must possess strong written and oral communication skills, ability to influence change/be a change agent, and be able to coach, mentor and train others

• Excellent knowledge and previous collaboration with regulatory guidelines

• Strong working knowledge of GxP and quality systems

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​​Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.