A booming BioPharma company is looking for a Quality Compliance Manager to add to their team.
As a Quality Manager you will be responsible for the implementation and sustainment of the GSK Quality Inspection Readiness Plan, Lead, Oversee, and support Quality individuals to ensure the programs are in place while aligned with requirements and expectations.
- Establish challenging but realistic goals that align with site objectives.
- Provide leadership to managers and associates that motivate them to achieve department goals and objectives.
- Work with internal teams to achieve and sustain activities to ensure site remains in state of inspection readiness every day.
- Lead and manage FDA and other regulatory inspections for the Site; write and coordinate the issuance of a fast response time to the Agency for any observations. Manage internal commitments to ensure timely follow-up and completion as obtained.
- Host Internal Corporate and External Audits and Manage internal procedures to ensure timely follow-up and completion as committed to the audit functions.
- Ensure robust product surveillance process ensure identification of proper actions throughout product lifecycle.
- Manage Site Internal Audit and Self-Inspection programs.
- Communicate and establish processes to ensure effective communication within the department, across functions and across sites.
- Approve GMP related documentation
An Ideal Candidate will have-
- Bachelor's degree in Science, Engineering, or similar.
- 5 years of experience in the Pharmaceutical Industry in Quality Assurance or Compliance.
Send Resumes if interested and lets chat!
