Back to jobs

Senior QC Manager

Job description

Job Title: Senior QC Manager
Role Type: Permanent, Full Time
Location: Dublin.

Our client is a leading pharmaceutical company based in Dublin, and they are looking to hire a Senior QC Manager on a Permanent, Full Time basis. This role reports directly to the site Quality Lead and oversees QC operations, working closely with a team of Specialists, Senior Analysts and Supervisors. This is a fully onsite role, and they are looking for an experienced QC Manager who can hit the ground running.

Duties & Responsibilities:
  • Day-to-day management of both chemistry and microbiology labs, which includes the release of raw materials, packaging components and finished products to meet the production and shipping schedules as appropriate.
  • Ongoing maintenance of the site stability programme.
  • Ongoing maintenance of the retain samples programme.
  • Liaise with manufacturing to ensure that raw materials, in-process lots and finished products are released in a timely and cost effective manner.
  • Ensure that all laboratory personnel are trained in their appropriate duties in GMP and GLP through a defined structure programme and that training records are updated on an ongoing basis.
  • Responsible to recruit and develop training plans as well as personnel development plans for all laboratory personnel.
  • Assist in the preparation for internal and external audits by regulatory bodies.
  • Carry out performance appraisals for QC laboratory personnel.
  • Ensure analysis and approval of all validation data in a timely manner and approval of validation documentation as required.
  • Ensure validation of test methods and method transfers are executed and documented as required.
  • Responsible for the safety of all laboratory personnel and notification of any safety concerns to Quality Director/EHS Advisor.
  • Responsible for the coordination and performance of the continuous improvement programme within the quality control laboratories.
  • Financial management of resources and expenses of the Quality control function within budget agreed. 
Skills & Experience Required:
  • Bachelor's degree in a relevant field, such as pharmacy, chemistry, biology or a related discipline.
  • Advanced degrees (Master's or Ph.D.) may be an advantage.
  • 5-7 years of leadership experience in quality control laboratory (chemistry/ microbiological) activities or a related area within the pharmaceutical industry with a focus on compliance with GMP and GLP.
  • A minimum of 5 years of people management experience.
  • In-depth knowledge of relevant applicable regulations and guidelines such as EMA, ICH, EP and other global regulatory requirements.
  • Experience in interacting and facilitating HA inspections and audits
  • Strong technical writing skills.

Benefits
  • 12.50% annual target bonus
  • Yearly salary review
  • VHI Health Insurance
  • Private pension from day one
  • Life insurance
  • 24 days of paid annual leave, increasing
  • Paid sick leave