Director, Quality Assurance
Company: Codiak BioSciences
Posted on: August 18, 2019
Reporting to the Head of Manufacturing Operations/Clinical
Manufacturing Facility (CMF) Site Head, the Director of Quality
Assurance is responsible for leading and strategically directing
the Quality organization and is accountable for the continuous
development, execution and administration of a GxP Quality System,
meeting all compliance requirements with respect to Good Laboratory
Practices (GLP), Good Clinical Practices (GCP) and Good
Manufacturing Practices (GMP). The Director of Quality Assurance
will develop, maintain, and continually improve Quality Operations,
the Quality Management System (QMS), the Quality Assurance program,
and the Training Program. He/she will also provide overall Quality
and Compliance oversight for the internal and external
manufacturing and supply chain process supporting Codiak's
products, including the development of the Clinical Manufacturing
Facility (CMF) in Lexington, MA. Responsibilities Quality
- Develop, implement and maintain Codiak's QMS to ensure
compliance with FDA/EMA/ICH and other applicable regulations and
- Ensure appropriate compliance and operational effectiveness in
all areas of the QMS. including, design control, document control,
change control, training, complaint handling, CAPA, and risk
- Establish eQMS system at Codiak. Audit Program
- Develop, implement and maintain a GxP audit and monitoring
plan, including establishment and management of related SOPs, a
risk-based audit and monitoring schedule, and a CAPA effectiveness
- Manage audit program against GxP standards, FDA/EMA/ICH
requirements, and other regulatory standards and ensure effective
and comprehensive quality oversight of selected GxP and contract
research/manufacturing vendors, including vendor assessment and
selection, Vendor Audits, Quality Agreements, etc.
- Develop metrics for Quality at Codiak CMF and contract service
- Establish and maintain appropriate development phase GMP
compliance for product manufacture, testing, and stability; review
and assess production and testing methods, specifications,
validations, reference materials and test results.
- Manage Quality Assurance relationships with GMP service
providers; work with CMO QA and technical teams to resolve
discrepancies, and noncompliance events.
- Provide Quality oversight to release and distribution of Codiak
products in alignment with regulatory guidelines.
- Review technical and study reports, CMC sections of regulatory
submissions, pharmacy manuals, investigator brochures, study
protocols and reports, as requested, for compliance with
established standards, and regulations.
- Recommend solutions to complex quality issues and work closely
with senior management to resolve significant compliance trends and
- Act as subject matter expert and company representative during
partner due diligence activities and regulatory inspections.
- Represent Quality Assurance in company project meetings to
ensure regulatory and compliance requirements. Training
- Partnering with Human Resources, manage and deliver SOP and GxP
related training to employees and external contractors, including
oversight of training.
- Ensure robust planning and execution of documentation for
product release. Qualifications
- Bachelor's degree, Master's degree or PhD in science,
pharmaceutical sciences or related field.
- Minimum 10 years of experience in Quality Assurance with at
least 5 years of experience in GMP pharmaceutical development,
manufacturing and testing.
- Preferred experience with complex biologics, Phase 1 through 3
stage product development. Technical knowledge of analytical method
qualification, process validation and establishing product
specifications a plus.
- Experience with outsourced manufacturing and testing
operations, as well as internal manufacturing facilities.
- Experience in working in compliance with US, EU and ICH GMP
requirements, experience reviewing submission documentation,
responses to regulatory inquiries and inspections.
- Demonstrated ability to work independently, handle multiple
tasks simultaneously, prioritize, negotiate and meet critical
- Excellent oral and written communication skills, with an
ability to shape, frame and present to diverse internal and
- Strong interpersonal skills to effectively communicate with
teams, peers, management and external contacts.
- Proven organizational and leadership skills to mentor and
develop cross-functional team to achieve Company goals.
Demonstrated ability to effectively lead professional staff
- Working knowledge of MS Office products including Word, Excel,
Outlook, PowerPoint, and Project.
Keywords: Codiak BioSciences, Boston , Director, Quality Assurance, Professions , Lexington, Massachusetts
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