Quality Control Manager

South Africa, Western Cape, Cape Town

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Summary

The Head of Quality Control is accountable for the safe, cost-effective, and efficient testing support of manufacturing, while in full compliance with Roche’s corporate principle, quality policies and standards. This position ensures market demands are met, safely, in adequate time and quantities, always seeking for balance between quality, competitive cost and time for manufacturing.

Responsibilities and Skills

Leadership and People Management

  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • As a leader within Operations Leadership team, drive network activities and alignment, cross-functional planning, and decision making.
  • Accountable for overall budget and financial performance of the Quality Control function.
  • Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
  • Embody lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

                                                 

Technical and Functional

  • Establish, modify, implement and enforce Quality Control policies, procedures, specifications and testing methods consistent with regulations, Roche standards, policies, plans, objectives and procedures.
  • Direct QC Staff in the timely completion of testing (release testing, raw materials, in process samples, utilities, direct materials and environmental monitoring).
  • Provide QC staff with technical guidance on test methods and relevant procedures.
  • Ensure timely generation and reporting of test results in support of manufacturing operations.
  • Ensure calibration and maintenance of laboratory equipment and systems.
  • Ensure support of manufacturing operations through troubleshooting, transfer activities and other product lifecycle testing.               
  • Ensure that data, documentation, and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
  • Ensure system, computer, change control, and analytical data is reviewed, evaluated and approved against established criteria.
  • Ensure data is generated, documented and reported following procedures and policies.
  • Direct the review and approval of all applicable Quality Control documents and ensure documents are updated.
  • Direct QC Staff in the timely resolution of issues, including discrepancies, investigations, and implementation of CAPAs.
  • Escalate any potential quality issues revealed during QC testing or processing of products, especially quality or regulatory issues with the potential to affect product quality or regulatory compliance. 
  • Support regulatory inspections and partner audits, approvals of protocols and reports of third party QC laboratories. 

Requirements

  • Master’s degree in Genetics, Biochemistry or a related subject.
  • 5+ years’ work experience in the diagnostic or related industry.
  • 2+ years’ experience at a management level.
  • Demonstrated experience and knowledge of Quality operations and processes.
  • Strong leadership, collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.

Roche is an equal opportunity employer.

Quality, Quality > Quality Control