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Director, CMC Quality Assurance

Ultragenyx Pharmaceutical

This is a Full-time position in Cambridge, IL posted January 5, 2021.

n n nn Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases.

The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.

nn nn Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA.

We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

nn nn Developing new treatments for rare genetic diseases is challenging work.

It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact.

At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

nn nn Come join our team during this exciting time of growth and opportunities!  During the COVID-19 Outbreak we are committed to our hiring process.

The health and safety of our employees and prospective employees take priority which means at this time our process will include remote based web-ex video discussions, interviews & onboarding.

nn nn POSITION SUMMARY nn nn The Director, Quality Assurance Validation is responsible for executing the Ultragenyx Gene Therapy (UGT) Validation Quality System at the new manufacturing facility located in the Woburn, MA area.

This manufacturing facility will include the entire product lifecycle; Cell banking, Drug Substance, Drug Product, and Pack/Label activities in an aseptic/sterile environment.

nn nn This role will partner with the Head of Validation and be the primary Quality representative responsible for completing equipment qualification, instrument qualification, facility and utility qualification, cleaning validation, process validation, and computer/software validation.

This role will be responsible for quality decisions related to all elements of the qualification/validation lifecycle.

The early lifecycle elements of this new manufacturing site include planning, design, and build/test.

This role will review and approve a high volume of validation plans, specifications, protocols (IQ, OQ, PQ), and validation reports to achieve aggressive project timelines to build out the new site.

nn nn Upon completion of the new manufacturing site, this role will evolve to focus more heavily on the remaining aspects of the validation lifecycle including operation, maintenance, and decommissioning.

This role will be responsible for the day-to-day Quality oversight of the validation program which includes qualification/validation of new equipment and processes, periodic reviews, requalification, and continuous improvement.

This role will be critical in driving inspection readiness for site licensure and maintaining a constant state of inspection readiness.

This role will also work closely with the UGT team and across the Ultragenyx Network to collaborate on various initiatives that enable best practice sharing and continuous improvement.

nn nn This position will be responsible for building and managing the Quality Engineering function and team at UGT.

The Director reports to the Sr.

Director of Internal CMC Quality Assurance Operations at Ultragenyx Gene Therapy.

nn nResponsibilitiesn Collaborate with UGT Facilities, Engineering, and Validation teams to develop the Master Validation Plan and individual validation plans.

Assist in the development of the overall validation strategy for the new site.

Write, review and/or approve validation documents including specifications (URS, SRS, DS, FS), protocols (IQ, OQ, PQ), and validation reports.

Ensure the project timelines are met.

Support investigations and actions related to validation deviations.

Incorporate Ultragenyx risk management principles into the validation program and daily decision-making processes.

Assure the validation requirements meets all applicable health authority requirements and industry guidelines.

Assure the validation documents are executed to meet these requirements.

Support ongoing manufacturing operations during investigations to resolve gaps, problem solve issues, or drive proposed improvements.

Support the change control and deviation processes to effectively evaluate and document evaluations and improvements.

Ability and willingness to work in a fast-paced environment that will require a combination of individual contribution and team leadership.

Develop appropriate metrics and KPI.

Prepare reports and present KPI metrics to senior management.

Help maintain a state of continuous inspection and/or audit readiness.

Lead discussions during health authority inspections.

Participate in responses/corrective actions to regulatory findings.

Collaborates with the GxP Compliance team for internal audits.

As applicable, manages findings, responses and corrections to address identified risk.

Maintain up to date knowledge of validation requirements, practices, and procedures.

Provide coaching and guidance to the Ultragenyx team members.

Drive or support continuous improvement activities to support elimination of waste to enable an effective and efficient manufacturing site/process.

Champion process improvement where applicable.

Promote a culture of quality, operational excellence, and value-add.

Hires, manages and mentors staff, performs performance reviews.

Ensures direct reports carry out their duties according to GxP principles.

Actively partners with the Global and Site Leadership Teams to support GxP operations, company projects and other activities.

Informs leadership of critical issues.

Collaborate across the Ultragenyx network to share best practices and improve processes.

Support the develop, maintenance, and continuous improvement of the Ultragenyx Gene Therapy validation quality system.

nRequirementsn Minimum B.S.

degree in Engineering or other Science field such as microbiology, chemistry or biochemistry.

A minimum of 12 years of experience in biopharmaceutical or biotechnology based GMP operations.

Most of the experience must have been in a Validation/Quality role.

Direct experience with facility, equipment, utility, and cleaning validation is highly preferred.

Experience is with cell culture and single use systems is also preferred.

6+ years of direct supervisory experience of technical or quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff.

Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.

Comprehensive knowledge and experience with automated systems and GAMP5.

Direct experience reviewing and/or authoring CMC sections of regulatory filings.

Excellent oral and written communication skills with strong technical writing experience required.

Excellent organizational skills and attention to detail.

Demonstrated analytical approach to problem solving and decision making.

Demonstrated ability to manage multiple priorities for complex projects.

Experience leading large continuous improvement efforts.

#LI-CZ1 nn Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at .

For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

nn nn Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department.

Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates.

Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization.

Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.

Inquiries on developing a recruiting relationship with us, may be directed to: .

nn n n