Quality Manager

Job overview:

The Quality Manager is responsible to support manufacturing and to advise on vendor onboarding, technical transfer and validation.

This role will act as a GMP/GDP advisor to the manufacturing and supply team for activities in the US. This role will also provide operational Quality support through QMS oversight and record management.

Location: Hybrid in our New York City office or Remote in the United States.

Reports to: Quality Director, Manufacturing and Operations.

Roles and responsibilities

(Include but are not limited to):

• Operational Quality Support

• Act as Quality point of contact for US GMP/GDP vendors and ensure requirements within QTA's are maintained with partners

• Quality oversight of GXP vendor qualification, process analytical and shipping validation, non-conformances and changes at vendors

• Quality oversight of technical transfer and validation activities at partners

• QMS

• Ensure that company Quality related processes are harmonised and standardised to drive compliance and improve efficiency

• Responsible to keep up to date with current and evolving regulatory requirements, including changes relating to GxP and requirements that impact the QMS

• Measure and monitor the performance of the QMS

• Generate and report KPI Weekly / monthly to internal business partners and Quality Council

• Track critical CAPA in the QMS to ensure delivery and reporting

• Act as a MasterControl superuser

• Quality SME

• Act as a Quality SME to support the business where required

• Training package creation and reviews

• Process flow design and reviews

• Lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness

• Provision of support to Quality Leaders as required

• Quality Risk Management

• Make Risk based Quality decisions

• Identify, assess, prioritise and address risks and opportunities

• Investigate non-conformances effectively and manage risks

Candidate Profile:

• Broad based knowledge of the pharmaceutical industry at least 10 years' experience in the industry

• Scientific/engineering degree or equivalent combination of education and experience

• Postgraduate qualification in Quality Management or equivalent combination of education and experience

• A proven understanding of GxP and Quality Management requirements as applied in the industry

• Excellent understanding of continuous improvement in a pharmaceutical environment, with a passion for continuous improvement and experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six Sigma

• Ability to identify appropriate KPI's, implement and use as control mechanisms and drive change and improvement.

• Excellent verbal and written communication skills, including the ability to interact effectively with different audiences.

• Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action.

• Good knowledge of GxP and pharmaceutical regulations

• Ability to influence and challenge others in a constructive way

• Good at prioritising tasks and delivering against milestones in a fast-paced environment

• Alignment to our company values