Job Description
We are seeking a QC Shared Services Senior Manager - QC Projects.
Reporting to the Quality Control Shared Services Associate Director, this position has responsibility for the learning & development management, QC Trending Management and execution of Continuous Improvement projects.
Why you should apply
- You will help patients in their fight against serious diseases
- You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
- You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 26.5 days annual leave, life assurance, on-site gym and gain-sharing bonus.
- Leadership of QC Shared Projects team to support manufacture, testing and release of Drug Substance and Sterile Drug Product
- Responsible for the Site Trending Program for Quality Control
- Responsible for delivering the QC Project portfolio in line with the overall QC Strategic 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.
- Prioritise safety in every aspect of the role
- Lead by example in exemplifying safety behaviours
Qualifications & Experience
- The successful candidate must possess a 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
- The candidate will have proven success working well in a team environment, as well as proven leadership skills to manage a team of professionals through changing business needs.
- 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; must be able to adjust to changing priorities and a dynamic work environment.
- The candidate will have demonstrated strong leadership and people / project management abilities as well as proven decision making ability. Additionally, the successful candidate must be able to interact with a broad range of disciplines and exert positive influence within internal matrix teams across a variety of functions.