*Snr. Director /Director, Quality Assurance

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The Director of Quality Assurance (QA) is accountable for leading and managing the day-to-day activities of the QA Operations department. The position will drive the QA organization to meet the site’s business objectives as the site increases its focus on commercial manufacturing and advancing development products through commercialization. The Director will be responsible for QA lot disposition and support of manufacturing, facilities, and QC.

KEY RESPONSIBILITIES:

  • Responsible for quality operations department and team in support of Manufacturing, Testing, and Disposition.
  • Lead and drive accountability of a diversified team of five QA departments.
  • Area consists of Quality professionals responsible for cGMP manufacturing of clinical and commercial products, including but are not limited to: raw materials/ drug substance batch record review and lot disposition, QA oversight of manufacturing activities, QA representative with customers, QA approval of product and process specific documents, QA oversight of site deviation review and approval and QA oversight of the construction, commissioning, qualification, and validation of a commercial manufacturing facility and the subsequent process validation activities.
  • Make and execute operational decisions with a strategic perspective
  • Support operations in continuous improvement initiatives by providing direction on requirements for proposed changes
  • Communicate strategic direction, quality policies/procedures and effectiveness of the Quality System at Management Reviews
  • Promote a culture of quality and accountability mindset, including continuous improvement through the establishment of KPI metrics
  • Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
  • Prepare quality documentation, metrics, and reports by collecting, analyzing, and summarizing information and trends including failed processes, target turnaround times and disposition dates, number deviations per batch, Root Cause/CAPA activities, etc.
  • Continually work to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions
  • Demonstrate effective change leadership by building strategic partnerships across functional areas to further departmental and organizational objectives
  • Provide support for internal and regulatory audits and inspections, as required
  • Other duties as may be required, according to the changing needs of the business

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to understand and apply GMP regulations as they relate to manufacturing, raw materials, testing and facility operations
  • Skilled in strategic thinking, managing through systems, communication and negotiation
  • Actively develops and maintains strong professional relationships building trust and respect across the organization
  • Lead through influence, effectively build alignment and collaborate with multiple stakeholders
  • Assess performance roadblocks and develop appropriate solutions
  • Willing to have difficult conversations, meetings, and make decisions related to readiness of areas for inspection
  • Facilitate organizational change related to quality systems across multiple functions

EDUCATION/EXPERIENCE:

  • M.Sc. in chemistry or life sciences or equivalent experience
  • 10+ years of relevant experience in a biotechnology and GMP environment
  • Direct experience leading or supporting multiple functions in a pharmaceutical, biotech or a regulatory industry is requires
  • Management experience, including a demonstrated ability to effectively lead staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated

Please send your application no later than the 16th of June 2023.

Please be aware that we take in consideration only the applications send via our career page and not via email. We will process the applications as they arrive.

For further information, please contact Andreea Rata at [email protected]



Want to keep posted about our growth and to learn more about our company?

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 26.5.2023, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Produktchef
  • København
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