Customer Quality Assurance Manager (CQA) at Merck Aktiebolag


Your role: The Customer Quality Assurance Manager is responsible for leading the Customer Quality Assurance (CQA) team. The CQA team is responsible for managing customer quality and regulatory requirements associated with the manufacturing of clinical and commercial APIs in a contract manufacturing environment. It is a highly dynamic customer facing position offering a world class experience for our customers.
A Customer Quality Assurance Manager’s primary responsibility is to manage the team that will support customer specific quality events such as batch release, validation protocol approval, deviations, RCA, CAPA, change control and inspection preparation and execution.
In collaboration with Project management, the CQA team is responsible for delivery performance of operations including prioritization, escalation and identification of bottlenecks, as well as providing a solution to deliver on the quality commitments each month and quarter. The CQA team is the primary quality point of contact between Millipore Sigma and the customer on quality related topics/issues during an active project.
Roles and responsibility: CQA possess detailed knowledge of cGMP and/or other relevant quality systems with strong evidence of collaborating in a matrixed environment. Highly developed interpersonal, written and verbal skills, including the ability to communicate with client and represent the Madison/Verona quality management system. The CQA must be able to establish strong collaborative relationships with all departments within the organization to deliver on customer commitments.
The requirements of the role include:
  • Lead and develop a team of qualified professionals to directly support strategic customer contract manufacturing projects.
  • Support and develop the CQA team to build strong professional relations with CMO customers.
  • Maintain and communicate a clear quality vision for the safe and efficient production of customer APIs and other GMP compounds.
  • Manage through collaboration with a site cross functional team the customer quality requirements as the project progresses through the pharmaceutical product cycle.
  • Manage the CQA team with overall responsibility for batch release for the client including all associated supporting documentation ensuring batches are released on time and in full.
  • Develop processes for notification management and approval of client/ product specific deviations within the agreed timelines. Work with a cross functional internal team to ensure investigations are conducted to meet customer expectation and timelines.
  • Collaboration with client on product/project specific CAPA and overall responsibility to ensure CAPA are effective and closed on time.
  • Generation and Management of Client specific quality KPIs.
  • Working with client and operations to initiate Change on behalf of the client and ensure successful execution of the change.
  • Conduct risk assessments for quality events and gaps between customer expectation and site capability.
  • Represent the client within Operations with quality oversight in manufacturing.
  • Manage and develop the role of quality Person in Plant (PIP).
  • Coordination of specific customer audits and assessments with the MS organization in collaboration with the audit team.
  • Point person for customer specific regulatory audits and audit preparation such as PAIs.
  • Preparation and attendance at all Client quality related meetings.

Who you are:

Education:
Minimum of a BS degree in a scientific field with a minimum of 5 years’ management experience in GMP quality or other functional area applicable to the job.

Experience:

Background in cGMP manufacturing contract manufacturing organization is desired and experience in managing a quality team is essential. The ideal candidate will have experience with direct management of customer specific quality projects as they progress through the pharmaceutical life cycle.

Knowledge and Skills:

Strong management and organizational skills, excellent verbal and written communication skills. They must be able to establish professional relationships with customers to ensure customer requirements are fulfilled within the agreed contacts. Demonstrated leadership ability to lead and motivate the customer quality assurance team. Must be able to communicate and proficiently discuss quality and regulatory systems with customer representatives as it relates to the customer projects. Madison

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