Director, Quality

Location
San Diego, CA, United States
Posted
Aug 23, 2019
Ref
236
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Job Summary:

The Director, Quality is responsible to develop and implement Quality Systems and infrastructure required for product, analytical, and clinical development programs. This role establishes a site Quality Unit capable of addressing all Quality requirements for product development and ensures effective implementation of quality processes and systems. The Director monitors site Quality functions to ensure Emergent products conform to Quality standards and GxP requirements. The scope of the role spans pre-clinical development through BLA submission.
  • Develop and implement Quality Systems and infrastructure required for product development in compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) regulatory requirements
  • Develop and implement review and disposition processes for clinical product batches
  • Provide guidance and Quality review of analytical development activities
  • Provide GCLP oversight of the Clinial Immunology Laboratory
  • Conducts the assessment of key quality outputs such as protocol deviations, product complaints, and audits
  • Develop and maintain site Quality Systems including documentation, training, and internal and external audit programs.
  • Manage the document control function ensuring all documentation is appropriately controlled and archived.
  • Monitor compliance for the management and conduct of clinical trials
  • Monitor quality systems performance through defined metrics
  • Ensure site Quality operations are aligned with EBSI Quality standards.

Responsibilities:
  • Ensure required Quality systems are implemented and maintained for the site
  • Acts as a Quality subject matter expert providing guidance to the Development, Manufacturing, and Clinical teams
  • Establish and maintain the site documentation management function
  • Approve Validation protocols and reports (method, equipment, facility, process, utility)
  • Approval of CMC project and submission documents including product, process, and analytical
  • Development protocols and reports
  • Manage the Deviation investigation, CAPA, and Change Control processes
  • Oversee the review, and approval of deviations, investigations and violations affecting ----Manage the site Supplier Qualification program and support contract service provider qualification
  • Quality management for CMOs and vendors
  • Review and revise standard operating procedures as required
  • Lead FDA and other regulatory agency inspections and support regulatory audits at third party suppliers and contractor service providers where required
  • Lead the internal and external audit functions
  • Trend GXP audit results to measure effectiveness of the Quality Systems and ensure appropriate corrective and preventive actions are taken
  • Review current changes in GXP regulations and industry best practice and incorporate those changes into the site Quality System
  • Provide oversight and direct site Quality resources to ensure appropriate support and compliance for all site development projects and operations
  • Maintain good relationships with Vendors, Contractors and Consultants to ensure effective execution of assigned tasks
  • Provide review and approval for Standard Operating Procedures (SOPs), documentation for use in manufacturing, packaging, testing and disposition of clinical supplies, clinical protocols, clinical protocol amendments, Investigator Brochures, and other quality related documents
  • Coordinate and/or conduct audits and reviews of technical, pre-clinical and clinical study reports and regulatory submissions to ensure appropriate quality for the intended purpose

Non-Clinical
  • Coordinate and support Corporate Compliance, as necessary, in conducting QA audits of potential non-clinical trial sites and Contract Research Organizations, ensure they are appropriately evaluated for suitability and audited in compliance with GLP when appropriate
  • Provide QA support for non-clinical study management
  • Ensure approved contractors provide compliant services

Preclinical CMC
  • Coordinate and support Corporate Compliance, as necessary, in conducting QA audits of potential manufacturing sites and ensure they are appropriately evaluated for suitability, and audited in compliance with cGMP
  • Ensure that Clinical Supplies are manufactured, packaged and tested according to appropriate quality standards, procedures and regulations.
  • Ensure approved contractors provide compliant services

Clinical
  • Coordinate and support Corporate Compliance, as necessary, in conducting QA audits of Contract Research Organizations, clinical trial sites, clinical databases, clinical study reports and clinical study files and ensure they are appropriately evaluated for suitability, and audited in compliance with GCP
  • Provide QA support for clinical trial study management
  • Ensure approved contractors provide compliant services to EBS

Leadership responsibilities:
  • Provide leadership and strategic direction to the specified quality site(s)
  • Develop staff to enhance capacity and ensure continuity of the Quality function
  • Ensure the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required
  • Establish strong relationships with internal and external customers-to build, enhance and ensure quality awareness
  • Collaborate with all departments to ensure that quality standards and GxP compliance are met and maintained

Education, Experience & Skills:
  • Minimum of Bachelor Degree (BA or BS) required in scientific field.
  • Minimum of ten (10) years experience in a FDA regulated pharmaceutical/biotechnology field.
  • Six (6) to eight (8) years direct management experience required.
  • Working knowledge of GMPs, GLPs, GCPs and ICH guidelines.
  • Ability to lead projects with minimal supervision.
  • Experience supporting GMP. GLP, and/or GCP operations in the biologics industry preferred
  • Strong understanding and application of cGxPs (ICH/FDA/EMEA) standards.
  • Experience in cGxP Quality oversight and auditing roles.
  • Experience with effective quality system execution in an FDA regulated environment.
  • Solid computer skills including MS Office required.
  • Experience with pre-approval inspection (PAI) readiness programs including hosting FDA or other regulatory inspections.


Physical/Mental Requirements:
  • Must be able to sit for long periods of time; majority of work is computer based.
  • Some domestic and international travel may be necessary.
  • Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 10 lbs., and pull 10 lbs. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.

Competencies:
  • Capable of management and implementation of quality systems.
  • Has the ability to make sound decisions based on experience and applicable regulations, i.e. must be able to review, and approved CAPAs, deviations, change controls, etc. with minimal supervision.
  • Has the ability to deal with competing timelines and multiple assignments.

Communication:
  • Strong communication (written and oral), negotiation, organizational, and interpersonal skills.
  • Must be able to collaborate and work effectively with multiple departments throughout the organization.
  • Must be able to work independently and as part of a team.

Performance measurement:
  • Improvement in quality systems performance by meeting predefined quality objectives.
  • Demonstrate compliance with internal procedures and applicable regulatory standards.