Sr. Manager, Quality Control

The Sr. Manager, Quality Control has the responsibility of managing and overseeing work of direct reports, managing individuals or a team, leading method transfer and validation activities, stability study coordination, management of external testing, write and approve CoAs, assay control, reference material and sample management, writing, reviewing and approving various QC related documents as required.

This role also requires performing QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) as required, setting up and maintaining systems and processes for QC Laboratory, scheduling, review and approval of tests results, management of the QC laboratory and interactions with other groups.

This position is based in Milton Park, and has a 5 day on site expectation.
Responsibilities:

• Manage direct reports including their training, scheduling of work, coaching well as

leading them to achieve departmental goals and objectives

• Lead QC assay transfer/validation activities to introduce new assays into QC lab

within given time frame.

• Set-up GMP compliant QC processes and maintain them appropriately for audit

readiness.

• Review and approve QC test data and CoA (Certificate of Analysis)


• Write, review and QC approve change controls, CAPA, deviations, protocols,

reports forms and templates related to QC operations as applicable.

• Lead investigations for OOS (Out of Specification), OOT (Out of Trend) results in

timely manner.

• Participate in regulatory inspections and submissions.


• Oversee and manage maintenance of QC laboratory and equipment.


• Lead QC laboratory equipment introduction and participate in equipment

validation.

• Oversee sampling and storage of QC samples and maintain inventory.


• Coordinate shipping and receipt of QC samples and other QC related material.


• Training others within department on methods and processes in accordance with

GMP practices.

• Become SME for QC methods, monitor method performance and lead trouble

shooting/ method optimisations as required.

• Interact within internal as well as across other functional group to communicate

QC requirements.

• Deputize for other roles during periods of absence or when responsibilities have

been delegated.

• Perform QC testing following Standard Operating Procedures (SOPs).


• Review and complete documentation in accordance with current Good

Manufacturing Practices (cGMP)

Other responsibilities

• Troubleshoot equipment and analytical methods


• Manage technical studies performed with external companies


• Represent QC at inter-departmental meetings and interact with external vendors,

as necessary.

Educational requirements:

• BA or BS in Chemistry/Biochemistry/Microbiology or other related science.


• More than 5 years GLP / GMP experience in a relevant work environment.


Experience and skill requirement:

• 6 years or GLP / GMP experience in a relevant work environment.


• Prior line management experience preferred.


• Computer literacy (including MS Word and Excel)


• Ability to work well with others and lead a team


• Effective communication skills


• Good organizational and time management