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Head of Quality - Maryland - Severn Maryland
Company: Disability Solutions Location: Severn, Maryland
Posted On: 04/19/2024
Position SummaryThe Head of Quality-Maryland is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to ensure the site is compliant with regulatory, Corporate, and customer requirements. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Head of Quality-Maryland is responsible for Quality, Validation and Quality Control and is the most responsible person for batch disposition. The Head of Quality will provide project guidance and support while working with customers to resolve quality concerns as appropriate.The Role - Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.
- Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.
- Interface with all other departments to ensure compliance with cGMP.
- Monitor site compliance to FDA, EU and all other applicable requirements.
- Analyze, resolve, or assist in solving compliance and customer issues.
- Ensure regulatory and customer audits are managed successfully and any responses are submitted in a timely manner.
- Prepare, approve, and manage Quality departmental budget.
- Approve or reject, starting materials, packaging materials, and intermediate, finished products, and evaluate batch production records.
- Ensure that all necessary QC testing is performed on manufactured products.
- Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures.
- Review and approve Site Annual Product Reviews.
- Ensure that required validation activities are completed.
- Responsible for ensuring the environmental monitoring and control of the manufacturing environment and plant hygiene.
- Require approval and monitoring of suppliers of materials. Ensure the proper designation and monitoring of storage conditions for materials and products.
- Actively participate in ensuring business measures/metrics are met (e.g. Customer service)
- Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required.
- Stay informed regarding industry trends, interpretation of regulations and application to the site.
- Being part of the Site Leadership Team representing the QRA function for the site and supporting site mission/strategyThe Candidate
- Bachelor's degree in chemistry or closely related field (e.g. natural sciences, engineering) is strongly preferred
- 10-12 years' directly related experience in pharmaceutical fields including managerial roles
- Experience with sterile drug product manufacturing and drug substance manufacturing is strongly preferred
- Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred
- Extensive knowledge of Quality Assurance and Quality Control
- Demonstrated expertise in effectively leading a sizeable organization with multiple levels and shifts, consisting of at least 100-150 employees.
- Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments
- Ability to bring projects to a timely completion using Catalent systems
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experienceWhy You Should Join Catalent:
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