Qc Associate Director

 

Description:

As QC Raw Materials and Compendial Associate Director you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.

 

In this role you’ll be reporting to the QC Director.

 

Your Responsibilities

 

• Key member of the QC leadership team. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.

• Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives.

• The role will require extensive liaison with counterparts and business leaders corporate to include the highest level of professional representation of the local site QC organisation.

• From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.

• Develop/build a world-class Biologics QC Raw Materials and Compendial testing team, including planning, recruiting/hiring, coaching/mentoring, and training for approximately 8-15 total headcount.

• Responsible for raw materials and compendial routine testing, method verification, and method transfer.

• Management of raw materials and compendial testing QC instruments and equipment

• Raw materials sample management, including sampling, sample login and disposition, as well as routine inventory checks of regulatory retention samples.

• Author technical documents, including relevant SOPs, testing protocols and reports, raw materials specifications, and raw materials expiries.

• Represent Raw Materials and Compendial testing teams in regulatory inspections and client and internal audits.

• Serve as a technical lead in applicable investigations, deviations, change controls, and CAPAs.

• Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.

• Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.

 

 

Your Profile

 

 

The ideal candidate for this position, will have the following:

 

 

Education

• University degree in related science/quality discipline required.

• Ph.D. with 5+ years of experience, or Masters with 7+ years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field, desired.

 

 

Knowledge/Experience

 

• 10+ years’ experience working within Quality Control/GMP environment with a well-rounded exposure to all areas in this field and significant experience with raw materials and compendial testing.

• Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project Management/supervision of personnel with particular attention to schedules and shifting priorities.