A QC Senior Manager (QC Projects) is required for a 12 month contract with a leading bio-pharmaceutical company in North Dublin. The successful candidate will take responsibility for the Learning and Development management, QC Trending management and the execution of QC Continuous Improvement Projects.
They will lead the QC Shared Projects team to support manufacture, testing and release of Drug Substance and Sterile Drug Product. The successful candidate will be responsible for the Site Trending Program for Quality Control and delivering the QC Project portfolio in line with the overall QC Strategy.
Previous management experience within a similar role in the pharmaceutical industry is essential.
Objectives
- Responsible for delivering continuous improvement initiatives to facilitate ongoing cost saving and performance excellence
- Develop a technical training structure and associated program to facilitate ongoing and consistent learning & development across the QC organization in line with the QC Network Strategy
- Ensures audit readiness, both internal and external
- Ensures the QC Projects Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations.
- Builds and fosters strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives.
- Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to QC
- Responsible for coaching, developing staff and completion of performance appraisal reviews.
- Inspires transformative thinking and motivates employees to deliver benchmark performance.
- Support QC planning and scheduling activities as required.
- Lead by example in exemplifying safety behaviours
Qualifications & Experience
- Bachelor/Masters in Science or Science related discipline and have a minimum of 6 years' experience in the Pharmaceutical Industry.
- Deep and demonstrated understanding and experience of the principles of GMP / GDP
- An accomplished people manager with the ability to motivate and develop departmental staff through effective feedback and coaching
- Works well in a team environment, as well as proven leadership skills to manage a team of professionals.
- Experience with interacting with regulatory agencies.
- Knowledge of US and EMA GMP regulations and guidance.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including chemistry and microbiological testing.
- Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments.
- Strong leadership and people / project management abilities as well as proven decision making ability
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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