- Manages the activities of QC staff primarily through the direction of dedicated QC Supervisors assigned to each operational area.
- Interacts with Quality, Business Development, Operations, Project Services, Logistics, and customer personnel to address quality issues.
- Ensures company’s adherence to cGMPs, SOPs, and customer instructions.
- Develops, implements, and continuously improves processes designed for the inspection and quality assessment of operational processes.
- Supports the site’s Product Classification program.
- Hires, trains, and develops Quality Control personnel.
- Serves as key trainer in cGMP and SOP training of Almac Clinical Services personnel
- Writes, reviews, and authorizes both site and global Policies and Standard Operating Procedures.
- Reviews and approves Quality Incident reports, Technical Query reports, Change Request documents, and Distribution/Depot Instructions.
- Supports the Supplier Quality department by collecting and communicating information regarding the quality of materials and services.
- Serves as a point of contact for client and internal customer representatives in regards to receiving, processing, and relaying quality information.
- Bachelor’s Degree
- A minimum 5 years’ experience in Quality Control related activities with regards to clinical Packaging
- Minimum of 5 years leadership experience in developing, assessing, and/or implementing processes within a GMP manufacturing, packaging or Quality Assurance/Quality Control environment
- Experience in direct supervision of personnel
- Degree in the biological, pharmaceutical, or chemical sciences preferred
- Experience with chemical/physical sampling and testing of raw materials, in-process materials, and/or finished goods is preferred.
- Experience in GMP and job skills training is desired.
- Full medical, vision & dental benefits the 1st of the month after start date
- 20 days of PTO to start plus 12 holidays per year
- Company paid long and short term disability along with life insurance
- 401k company match
- Professional development programs/ continuous learning opportunities