This position will be responsible for the implementation and maintenance of a structured business process for all QC metrics. This includes responsibility for monitoring, statistically analysing, trending and reporting of QC data/metrics to evaluate performance and risks.
This manager will also be responsible for compiling data and developing analysis to support QC investigations.
- Liaise with planning teams (internal and external) to create, maintain, and communicate, the finite QC schedule.
- Implement and manage a structured business process to ensure all QC work (standard/non-standard) is captured and up to date.
- Actively engage with the Laboratory management team to implement and maintain a system for capacity planning and demand forecasts.
- Compile data and develop analysis to support QC Investigations, KPIs and other QC Reports as requested
- Continuous Monitoring and Trending of QC metrics/KPIs and report out daily / weekly / monthly metrics as appropriate.
- Participate in CI across planning, metrics and scheduling activities.
- Work as part of a cross functional team to achieve results in relation to deliverables.
- Perform other related duties and special projects as required or requested by QC Director
- Degree in Science or equivalent in life sciences/bioengineering/information systems.
- Statistical qualification a strong advantage
- 8 plus years of experience within a pharmaceutical/GMP manufacturing facility.
- 8 to 10 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in Lean Tools/Statistics
- Hands-on experience as a project manager
- Passion for continuous improvement and demonstrated problem solving skills
- Must be able to work on own initiative
- Ability to efficiently use current computer packages in particular Excel, PowerPoint, MS Project and Word.
- An ability to deal with process change and implement new effective processes.
- Excellent interpersonal and communication skills.
- An ability to work with peers and across organizational boundaries.
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes’ list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.