A Major Medical Devices Company in Galway City, Ireland wish to recruit a suitably qualified person for the following post:
SENIOR CHEMISTRY LABORATORY MANAGER
The Senior Chemistry laboratory Manager will be responsible for leading a workgroup of managers/supervisors, chemists and scientists, and technicians who perform testing studies supporting regulatory submissions, including ISO 10993-18, EU MDR, MD SOTA, and material of concern for an Analytical Chemistry laboratory within a regulated medical device industry. The position has responsibility for people management, seamless partnership with teams supporting the entire biocompatibility lifecycle, collaborating with the clients to understand testing needs and define testing plans, providing work direction to analysts, work prioritization, data and report review, and leading lab improvement projects. The position will also partner with lab leaders in other geographies to ensure standardization, and with leadership on strategic planning.
* Manage and coordinate the day-to-day activities of the workgroup including work direction, prioritization, and training.
* Work seamlessly with peer organizations to ensure technically sound, timely, and compliant regulatory submissions
* Partner with the lab's clients to define testing needs, priority, and resource planning.
* Perform detailed technical and quality review and approval of lab notebook entries and reports.
* Author, review and/or approve laboratory reports, test methods, and standard operating procedures (SOPs).
* Partner with lab quality on an ISO 17025 quality system and ensure compliance to department processes
* Manage department metrics and own/drive countermeasures when needed.
* Provide support for lab quality activities including Out of Specification investigations, CAPAs, audits and inspections.
* Lead lab improvement projects with a focus on improving client support levels and increasing operational efficiency.
* Manage change by developing materials and facilitating meetings to gain employee feedback, inform employees, influence behavior, drive decisions, and set policies.
* Provide performance feedback and career development through regular mentoring and coaching.
* Hire top candidates and help them successfully integrate into the department.
REQUIREMENTS:- Key Skills, Qualifications & Experience
* Masters degree or PHD level in Chemistry, Materials Science, Physics, Engineering, or
related technical discipline ideally
* 5-10 Years experience within Medical Device Industry is essential
* Strong chromatography (liquid and gas) and mass spectroscopy experience and expertise.
* Demonstrated technical leadership skills in defining test plans, data interpretation,
and providing technical recommendations to project teams.
* Record of developing and maintaining strong working relationships with internal and
external stakeholders to influence the outcome of important decisions or initiatives.
* Experience managing change, managing/leading others, coaching and providing performance
* Proficiency authoring and editing technical reports, business correspondence and
quality systems procedures.
* Ability to effectively present information and respond to questions from groups of
executives, managers, and clients.
* Quality, reliability, or other regulated industry experience, including knowledge of
ISO 17025, cGMPs, and 21CFR11.
* Experience working across organizations to achieve business goals.
* Excellent interpersonal, verbal, training, and presentation skills.
* Expertise with ISO 10993, especially part 18, EU MDR chemistry testing, MD SOTA
chemistry testing is essential
* Expert in testing of medical device for leachable and extractables using one or more
techniques of GCMS, LCMS and ICPMS.
* Expertise in liquid and chromatography method development and validation.
* Experience developing budgets and managing departmental costs.
* Experience leading Lean or Six Sigma projects and/or project portfolios.
* Experience and knowledge in Project Management.
* Knowledge of Quality System Regulations in the areas of Chemical Testing, Laboratory
Investigations and CAPA.
Ability to travel to the USA will be required at the beginning of this role.
A competitive Salary and flexible Benefits Package is on offer.
If interested in applying for this post, please email your CV in Word Format to:
Informal enquiries in the strictest confidence to Christy on 087 -9473404 and 00353 87 9473404 (if outside Ireland)