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Head of Pharmaceutical Quality

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Ireland
  • Sector: Quality & Compliance
  • Date posted: 06/02/2018
  • Job reference: J381204A

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Our client, SK biotek, are looking to recruit a Head of Quality to head up their pharmaceutical Quality operations in Ireland and South Korea.

This position is responsible for developing, maintaining and continuously improving the quality assurance and compliance needs in the Good Manufacturing Practices, (GMP), at Manufacturing & Supply facilities located in Ireland & South Korea as well as potential future additional SK biotek sites. The incumbent will ensure quality practices match global regulatory agencies and comply with our client’s quality assurance and compliance requirements. This position is responsible for products in development and commercialized. He/she will be responsible for setting and communicating the QA vision, strategy, and organizational structure to meet the SK biotek’s strategic goals.

Experis are the exclusive recruitment partner to SK biotek Ireland for this role

Responsibilities include but are not limited to:

  • Provide quality leadership to manufacturing plants in Swords, Ireland, Daejeon South Korea and Sejong South Korea plus potential future additional SK biotek sites.
  • Own responsibility for all regulatory and compliance activities within the regions and lead the Global quality organisation.
  • Create and maintain a high level of commitment to quality and compliance. Understand the regulatory environment and work proactively to assure that the state of the industry is anticipated and maintained.
  • Create, maintain and ensure the global process for regulatory inspections and inspection readiness preparation is in place, up to date and followed.
  • Oversee global Regulatory Agency interactions related to compliance issues.
  • Communicate effectively and build cooperative and supportive working relationships with all manufacturing sites.
  • Maintain positive relationships inside and outside of the Company, including regulatory agencies and SK biotek business partners and suppliers.
  • Lead and develop staff to achieve professional growth and attain established goals and a robust succession plan.
  • Approve methods and specifications for pharmaceutical products.
  • Implement policies and procedures consistent with regulatory compliance. Ensure adherence to QC/QA procedures, policies and guidelines.
  • Implement systematic corrective action. Anticipates regulatory trends and establishes systems to minimise GMP compliance impact to each site and the Company.
  • Lead fact finding during investigations.
  • Maintains oversight of departmental spending. Reviews budget and conduct oversight of periodic projections of spending against budgets.
  • Participate and contribute to site Quality Councils and SK biotek governing Quality Council to ensure that management with executive responsibility are appropriately informed and aware of the suitability and effectiveness of the quality system and significant events.
  • Approve the Quality Plan for each site and subsequent revisions as required.

Qualifications:

  • Bachelor's Degree in Science, Masters of PhD in Life Sciences preferred.
  • 12-15 years applicable experience within the Pharmaceutical Industry including a minimum of 5 years of API Manufacturing QA / QC experience of Validation and Process/Analytical methods.
  • Experience as the quality leader for a manufacturing site and ideally has experience in a headquarters/regional leadership role. More broadly, the successful candidate understands the business and marketing aspects of pharmaceutical operations and a highly regulated industry, as well as the relevant implications in evaluating the potential impact of product decisions.
  • Prior responsibility for managing a large budget, and achieving profit and loss objectives.
  • Significant experience with FDA and EMA regulatory authority interactions, including PAI & GMP inspections.
  • Proven ability to lead and motivate employees in all operational areas of the Company.
  • Demonstrated technical expertise in API and pharmaceutical product and has aseptic experience that extends to finished drug product.
  • Ability to build strong relationships, lead large, complex organisations, and work across diverse cultures.
  • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organisation.
  • Excellent influencing and negotiating skills for interface with regulators.
  • Strong project management and execution skills, and is able to manage multiple projects and prioritise as needed. Ability to plan and conduct projects within a multi-disciplinary environment.
  • Willingness to Travel with International Travel at a 35% requirement.

If you are interested in this role, please call Aine Fanning Experis Life Sciences Director for a confidential discussion on 01 6455245 or email aine.fanning@experis.ie

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