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QC Chemistry Manager - Ireland
Posted on : 13 May 2017
- The QC Analytical manager manages all aspects of QC analytical / bio-analytical laboratory at our company including technical, regulatory and systems reporting to the Director of QC.
- This position manages the QC analytical team to support timely and compliant testing for the company products for internal and external manufacturing facilities.
- Manage the QC team, to allow the laboratory to perform as an in-process, release and stability testing environment.
- This role will assume accountability for non-direct testing activities
- Manage all network support activities and ensure they are delivered on time and within budget
- Represent and support the laboratories for all Investigations
- Represent QC at product and technical team meetings and lead/drive all associated support activities
- Liaise between QC test team and all customers both internal and external
- Lead QC product report out to management, senior management
- Liaise with external support to ensure all requirements are delivered on time and on budget
- Responsible for QC support of the APQR process and Process Monitoring support
- Manage all activities supporting QC analytical, outside of testing and release of the batches
- Drive process efficiencies, tracking and reporting on improvements including cost, productivity and waste/rework
- Lead QC inspection readiness for regulatory inspections
- Support management in continual enhancement of the QC strategic plan
- Implement and ensure team adheres to all HR Policies as appropriate
- Manage Kronos time management for all FTE’S & Report out performance
- Personnel development, SMART objective setting and coaching completing regular One: Ones with all direct reports
- Headcount maintenance and recruitment including permanent and contingent workers.
- Develop CI capability and utilize CI tools to drive improvements within your area
- Proactive engagement with key stakeholders.
- Recognition is actively practiced by you and your team
- Best practices developed and shared with other teams /sites.
Education and key competencies:
- B.Sc. degree in biological, /chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
- Preferable 5 – 10 years’ experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally 5 years of that with supervisory/ leadership experience
- Demonstrated ability to successfully collaborate, influence and lead in a matrix organization
- Excellent communication and interpersonal skills
- Proven record in demonstrating agility
- Flexibility to travel in support of the role
- Have experience in representing your functional area on a network team
- Experience of involvement in technical issue resolution, in a multidisciplinary environment
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas