Sr. Director – Quality – API External Manufacturing – Peptides

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Position Brand Description:

The Sr. Director – Quality – API (Peptide) External Manufacturing is the Site Quality Assurance Leader for Peptide products within API EM.  The Quality Sr. Director is responsible for ensuring the ongoing robustness and continuous improvement for peptide activities, and personnel at the site.  The Quality Sr. Director also ensures that products are manufactured and released in accordance with marketing authorization requirements and cGMPs.

Key Responsibilities:

• Establishing and operating a quality management system for API Peptide External Manufacturing
• Ensuring staff are qualified and that the required training of all quality personnel is carried out and adapted according to need.
• Establishing a batch release process.
• Establishing a system to release or reject materials and intermediates.
• Ensure the evaluation of batch production records.
• Ensure all necessary testing is carried out in a compliant manner.
• Approving specifications, sampling instructions and master batch records.
• Ensuring robust control strategies are developed and maintained for the API Peptide EM portfolio of products.
• Approving and monitoring any analyses carried out under contract, consistent with technical and compliance expectations.
• Ensuring that effective systems are used for maintaining equipment and facilities, including contract laboratories.
• Ensuring that processes, equipment, utilities, methods and facilities are validated or qualified as appropriate and that related protocols and reports are reviewed and approved.
• Ensuring the technical rigor of documentation.
• Ensuring effectiveness of the site’s quality system including performing self-inspections.
• Ensuring quality agreements are in place and maintained.
• Ensuring critical deviations, OOS and complaints are investigated and resolved.
• Ensuring appropriate stability data to support storage and retest or expiration dating periods.
• Participating in and approving annual product reviews.
• Notifying senior management of significant quality related issues.
• Ensuring timely closure of all regulatory commitments.
• Ensuring that information related to the quality of the product is disseminated to those directly responsible for the quality and release of the product.

Authorized members of the quality unit can perform the activities, but the site quality leader maintains ultimate responsibility.

Key Responsibilities shared between the site quality leader and the operations leader:

• Ensuring and monitoring compliance with local regulations and the requirements of the GMPs.
• Authorizing written procedures and other documents, including amendments.
• Ensuring performance and evaluation of in-process controls.
• Inspecting, investigation, and taking samples to monitor factors that may affect product quality.
• Monitoring and control of the manufacturing and laboratory environments.
• Designating and monitoring storage conditions for materials and products.
• Validation and qualification activities.
• Ensuring the adequacy and effectiveness of the personnel qualification and training program.
• Ensuring manufacturing plant hygiene.
• Approving and monitoring suppliers of material.
• Approving and monitoring contract manufacturers.
• Record retention.

Authorized members of the operations or quality unit can perform the activities, but the site quality leader maintains ultimate compliance responsibility.

Key Objectives/Deliverables:

• Serve as the Site Quality Assurance Leader to the API Peptide EM Lead Team.
• Ensure site compliance to all cGMPs, procedures, standards, guidelines and regulatory commitments.
• Support quality related forums (e.g., Technical Review Boards) required to maintain continuous improvements.
• Ensure the creation and maintenance of a site Quality Plan and monitoring of metrics to deliver a complaint quality system.
• Coordinate and manage regulatory inspections.
• Review and approve documents supporting manufacturing and quality systems (e.g., procedures, deviations, changes).
• Ensure there