21 days old

Quality Site Head, iNeST (formerly PCV)

Roche
Hillsboro, OR

Quality is a competitive advantage for Genentech/Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Our philosophy â which permeates across the entire Pharmaceutical Technical Operations organization â is that quality is every patientâs right and every employeeâs responsibility. 

The Genentech individualized Neoantigen Specific Therapy (iNeST - formerly Personalized Cancer Vaccine (PCV) ) Facility Quality Site Head in Hillsboro, Oregon is accountable for the quality of the clinical, commercial, and launch products manufactured at the site and will ensure compliance with valid specifications and cGMP requirements. This new facility will be essential for the start up and commercialization our iNeST program and bringing this exciting new therapy to patients.

This role will be instrumental in creating a purpose-built quality system and driving innovation for speed.  This role will also be responsible for Quality Oversight of the design, build and commissioning of the manufacturing and Quality Control facilities and for establishing the overall site Quality organization.  The iNeST Quality Site Head is a member of the Quality MU Leadership Team, an extended PTQ LT member, a member of the Site Leadership Team and partner to the Site Head. 

Key Responsibilities:

Quality Management:

  • Accountable to ensure that manufactured product meets Health Authority regulations, Company standards and expectations.
  • Develop strategic goals and objectives to support the monitoring, review, testing and timely reporting on the quality of Roche/Genentech products.
  • Provide leadership and guidance to staff directing Quality functions, manage performance and development of direct reports to ensure achievement of organizational and departmental goals and a productive environment
  • Proactively prepare for and manage Health Authority inspections by ensuring the site is operating in an âœinspection readyâ manner at all times. Prepare adequate and timely responses to any inspection observations and implement appropriate and thorough corrections, as necessary.
  • Maintain an effective Quality governance and continually improve the governance to meet business and compliance needs.
  • Perform other tasks as requested by Executive Management to support Quality oversight activities.
  • Ensure that the in-process analytics and quality control comply with regulatory requirements.
  • Ensure that the quality of the source materials for the production comply with the product-specific and legal requirements
  • Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.

Leadership:

  • Develop and communicate organizational strategies, which ensure the GMP compliance of the site, continuous improvements and achievement of long term goals.
  • Lead, coach, and guide the organization.  Manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth.
  • Build a strong pipeline of talent and robust succession plans for key positions.
  • Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.
  • Be the champion and advocate for Engrained Quality at the Site.
  • Build a culture of continuous improvement and model lean leadership principles.

Collaboration:

  • Partner with the Site Head on strategic business direction and decisions.
  • Build and maintain strong partnerships with other site and network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationship.

Financial:

  • Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources.

Technical Duties/Responsibilities:

  • Serve as final decision âmaker and spokesperson for the Quality Unit.  This role is the decision maker for the Quality Unit at the site including heading the Quality Review Board.
  • Establish and manage the Quality Unit organizational, managerial and accountability structures.
  • Direct and provide guidance on all Quality matters, ensure and manage interfaces to other relevant Quality Units.
  • Define the strategies needed to reach the site and network goals. Develop and communicate goals and metrics to ensure achievement of goals.
  • Directly responsible for product testing, product assessments and product disposition to meet standard lead-times
  • Provide technical direction and leadership to support the timely resolution of discrepancies and investigations,
  • Provide technical direction and leadership to support routine audits as well as regularly visit manufacturing floor and QC laboratories.
  • Lead Health Authority inspections and Third Party audits at the site and support other sites during inspections and resolution of network issues/risks s required.
  • Work with internal business partners to proactively identify, communicate, resource and manage Quality and Compliance Risks in a timely manner. Ensure risks are managed to maintain our right to operate and quality supply to patients.
  • Provide expert interpretation and sponsorship of PQS requirements to ensure that the site is operating in compliance to company requirements.
  • Sponsor or lead the site Quality Council, chair the site Quality Review Board and be an engaged active member of network quality boards.
  • Be a strong network partner through sharing of best practices and lessons learned.
  • Actively develop employees, create of a climate of continuous improvement, high engagement and motivation, flexibility and agility.
  • Build strong partnerships with the site leadership team to assure alignment around strategic priorities and day to day priorities.â¨
  • Approval of contracts with quality relevant content (e.g. Quality Agreements)
  • Lead and manage the Safety Health and Environment elements of the organization appropriately.

QUALIFICATIONS:

  • Bachelorâs degree in Life Science, Pharmacy or related subject. PhD considered an advantage.
  • At least fifteen (15) years in the Pharma/Biopharmaceutical industry with 10 years working in Quality, Compliance, Regulatory and/or Validation, preferred.
  • At least eight (8) years of experience at a management level.
  • Start-up, innovation and novel therapy experience are an advantage.
  • Excellent knowledge of the Swiss Medic, European, US and International cGMP regulations and the QM/QRM techniques with an ability to adequately interpret and implement quality standards.
  • Demonstrated experience and knowledge of Quality operations and processes.
  • Experience in directing and leading large successful organizations.
  • Demonstrated experience in European, US and other relevant Health Authority inspections.
  • Strong leadership, collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
Posted: 2018-12-25 Expires: 2019-01-24

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Quality Site Head, iNeST (formerly PCV)

Roche
Hillsboro, OR

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