Director of Quality / Vacaville, California

Location
Vacaville, CA
Posted
Jan 24, 2022
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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.