Director of Quality / Vacaville, California

Director of Quality / Vacaville, California

ROLE SUMMARY

The Director of Quality is responsible for leading the Quality Team in maintaining all aspects of quality within a
highly collaborative and cross-functional environment ensuring product quality, compliance and customer
satisfaction for both in-house and CDMO products. The Director of Quality manages the Quality Assurance and
Quality Control departments and is responsible for the following functions: release and stability testing; method
validation; environmental monitoring program; CMC-related regulatory activities; raw material quarantine,
inspection, sampling, testing, and release; lot release; deviations and CAPA; supplier management and internal audit
programs; document and change control programs; training program; facility and utility quarantine and release;
complaints and product returns; and drug product shipping. This individual will need to build systems/processes
and organize resources to establish and achieve product release cycle time targets and meet project due
dates/deliverables. Additionally, the Director of Quality will be responsible for establishing a scalable quality
system to support the future growth of a multi-product GMP manufacturing facility, including PAI preparation and
implementation of computerized quality systems.

ROLE RESPONSIBILITIES

• Ensuring Polaris quality requirements are compliant with the appropriate regulations by various regulatory
  bodies/entities.
• Approve or reject drug products for clinical and/or commercial distribution.
• Approve or reject all procedures, specifications, validations, and changes impacting the regulatory
  commitments for Polaris products.
• Provide guidance and overall business strategy to QA and QC personnel in maintaining the quality functions
  to support the master production schedule.
• Partner with the Production and Facility departments to create and maintain the site Master Validation Plan.
• Provide development opportunities for reporting staff and maintain overall training methodologies for all
  quality associates.
• Responsible for hosting audits of Polaris by regulatory authorities, qualified persons, clients, and partners.
  Support audits and investigations, reviewing/approving technical content to ensure scientific merit and
  compliance to regulations.
• Ensure the Polaris external audit and internal audit programs meet current business strategies and objectives.
• Management of raw material introduction, review, and release system for all materials used in drug
  manufacturing.
• Responsible for the leadership of quality control functions including cGMP analytical method development,
  testing, validation, and routine QC laboratory operations.
• Management of the product review and release system.
• Management of Change Control and Document Control Systems.
• Keep up to date of current Quality Standards and Regulations impacting the biopharmaceutical industry.
• Responsible for organizing Quality Management Review and compiling and reporting on the performance of
  the quality system.
• Develop and recommend quality system improvements to support future business strategies.
• Oversee the development and maintenance of the stability program. Review stability data and stability
  reports, providing guidance where needed.
• Oversee investigations for “systemic” quality events at the site, including resolution strategies, CAPA
  implementation, and Material Review Board decisions.
• Provide leadership with respect to sample scheduling and daily process prioritization.
• Holds self and others responsible to abide by department and company policies and practices.
• Implement system improvements and procedural revisions, with emphasis on increasing laboratory efficiency,
  accuracy, and safety.
• ttend all department meetings, support discussions and formulation of ideas for laboratory infrastructure
  improvements and method optimization.
• Perform trend analysis/reports and critical thinking to the progression of the environmental monitoring
  programs, method validation, investigations, technical studies, and method transfer protocols.
• Oversee site-related CMC activities.
• Final sign-off on all product labels, package inserts and Marketing Material.
• Determine the financial needs of the Quality departments to create and manage an annual budget that is
  consistent with strategic direction, division needs, and stakeholder expectations.

SKILLS AND EXPERIENCE

• Ability to manage complex projects involving multiple functions
• Ability to gain consensus on key quality/operational decisions
• Strong analysis/problem solving skills
• Strong attention to detail/quality focus
• Balanced cost/quality/customer focus
• Ability and willingness to provide leadership to the entire group, with proficiency in both facilitating active and
  open discussion, and laying groundwork for logical decision making.
• Ability and willingness to collaborate with and influence other groups in a positive, team-based environment.
  Must also be able to hold others to account as required.
• Work with a sense of urgency and have the ability to be impartial and objective.
• Excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and
  be team focused.
• Excellent organizational skills.
• Be an active learner and developer of self and others.
• In-depth knowledge of International Standards, GLP, and GMP
• Experience with GMP, analytical, and environmental monitoring/analysis preferred.
• Experience in hosting and leading FDA and other regulatory authority audits, would be an advantage.
• Experience in developing and delivering effective training on Quality Systems and Processes is preferred.

QUALIFICATIONS

• B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). 8-12 years of relevant management
  experience in a biopharmaceutical quality field is desired.
• MS Degree in Science/Related Field (major in biology-biochemistry-chemistry). 5-9 years of relevant management
  experience in a biopharmaceutical quality field is desired.
• PhD in Science/Related Field (major in biology-biochemistry-chemistry). 3-6 years of relevant management
  experience in a biopharmaceutical quality field is desired.