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Form of workJob Description
Hybrid role - 3 days a week onsite
Create revise and approve *** Phase Appropriate Quality Systems documentation
Represent Clinical Quality Department in cross functions forums.
Draft and approval of Quality Technical Agreements with CDMOs as required for internal support
Provide quality oversight for internally manufactured early-stage products and starting materials
Provide support to audits and inspections of CDMOs and internal manufacturing and testing organizations
Provide quality oversight of one or more portions of operations including, but not limited to:
Release clinical phase 1 and 2 materials ensuring compliance with phase appropriate lot release requirements.
Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities.
QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations
Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs.
Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
Perform QA Walkthroughs for 300 BMK manufacturing product changeovers
Review and approval of SOP revisions initiated by manufacturing, Facilities and Engineering and Analytical support for 300 BMK Operations
Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments.
Ensure manufacturing and adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).
7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions.
Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required.
Computer literacy required, including Microsoft PowerPoint, Word, Excel.
Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues.
Results oriented; effectively manages a multitude of projects efficiently.
Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported.
Experience managing internal and external project stakeholders.
Excellent written and verbal skills; ability to communicate effectively with all levels of the organization.
Builds relationships with other functions, shares best practices, and solves shared problems.
Demonstrates in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally.
Demonstrates substantial knowledge of industry best practices and trends.
Positive, solution focused outlook on daily challenges.
Create revise and approve *** Phase Appropriate Quality Systems documentation
Represent Clinical Quality Department in cross functions forums.
Draft and approval of Quality Technical Agreements with CDMOs as required for internal support
Provide quality oversight for internally manufactured early-stage products and starting materials
Provide support to audits and inspections of CDMOs and internal manufacturing and testing organizations
Provide quality oversight of one or more portions of operations including, but not limited to:
Release clinical phase 1 and 2 materials ensuring compliance with phase appropriate lot release requirements.
Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities.
QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations
Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs.
Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
Perform QA Walkthroughs for 300 BMK manufacturing product changeovers
Review and approval of SOP revisions initiated by manufacturing, Facilities and Engineering and Analytical support for 300 BMK Operations
Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments.
Ensure manufacturing and adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).
7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions.
Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required.
Computer literacy required, including Microsoft PowerPoint, Word, Excel.
Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues.
Results oriented; effectively manages a multitude of projects efficiently.
Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported.
Experience managing internal and external project stakeholders.
Excellent written and verbal skills; ability to communicate effectively with all levels of the organization.
Builds relationships with other functions, shares best practices, and solves shared problems.
Demonstrates in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally.
Demonstrates substantial knowledge of industry best practices and trends.
Positive, solution focused outlook on daily challenges.
