Associate Director / Director, CMC QA
Company: Ultragenyx Pharmaceuticals
Location: Novato
Posted on: January 11, 2021
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Job Description:
Why Join Us?Be a hero for our rare disease patientsUltragenyx is
a commercial-stage biopharmaceutical company committed to
developing novel therapies for the treatment of rare and ultra-rare
genetic diseases. The company has rapidly built a diverse portfolio
of small molecule, monoclonal antibody, mRNA and gene therapy
candidates with the potential to address 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. 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.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 WebEx video discussions,
interviews & onboarding.Position Summaryultrafocused --- Work
together to fearlessly uncover new possibilitiesThe Associate
Director/Director, CMC QA will maintain strategic responsibility
over QA Manufacturing Operations and will implement and communicate
Ultragenyx---s CMC quality approach for the company. This role will
direct and oversee operations in accordance with GxP regulations
and Ultragenyx standards. This is an individual contributor role.
Responsibilities including, but not limited to:Collaborate with
Management and lead strategic interactions with internal and
external customers to negotiate actions impacting implementation
and supply of quality product to patients from design/development
stages to and including commercial operations.Design, develop, and
lead efforts for QA oversight of the manufacture and disposition of
pre-clinical, clinical and commercial product materials, DS, DP and
Finished Goods at CMOs in partnership with Technical Operations,
Product Development, Supply Chain and other functions.Manage and
develop processes and talent that provides overall Quality
oversight to CMOs that manufacture small molecules, biologics and
novel therapeutics (i.e., mRNA).Deploy resources to and/or
negotiate and manage quality agreements.Help ensure quality of
products produced / maintained at CMOs through review and approval
of cleaning, sterilization and process validation, process
simulations, shipping qualifications, equipment/facility/utility
qualifications, deviation investigations, lot release, significant
changes, and CAPA development related to manufacturing of
Ultragenyx products, and work with Technical Operations and our
CMOs to resolve recurring problems with permanent solutions.
Execution of Quality Systems in an Owner/SME or QA role, for
Deviations, Change Controls, Risk Management, Quality Review Board,
and Annual Product Quality Review. Lead and actively participate in
Continuous Improvement initiatives and projects, ensuring a focus
on increasing both efficiency and quality output from all processes
used by the CMC QA and cross-functional partners.Ensure development
and monitoring of quality metrics at the CMOs that predict the
performance and health of the quality systems and
processes.Represent Ultragenyx to health authorities as a company
expert.Knowledge of clinical and commercial supply chain including
orphan drug distribution channels, early access programs and
partner management Assume leadership roles in CMC teams as assigned
(either as an active participant or as a CMC lead).Ensure
completeness of technical evaluation and quality due diligence
activities in support of CMO site selection process Provide
stewardship of the quality risk profile and team risk; log and
approve risk controls strategies at CMOs both in the selection and
manage phases. Author/Reviewer CMC BLA, INDs, MAA and other
relevant regulatory dossier sections based on area(s) of knowledge
and expertise. Strategize responses to regulatory questions during
review period and product lifecycle. Participate in Governance
support teams at CMO sites. Act as co-auditor during cGMP audits at
CMOs, when requested by Inspection Management.Collaborate with CMC
Leads and Portfolio Management partners to ensure successful
planning, execution and delivery of projects.Design, develop, and
review CMC QA standards and procedures (i.e., policy documents and
SOPs). Review and support deployment of Quality Standards generated
by the Quality System Department.Ensure activities and deliverables
are in compliance with FDA, EMA and local regulations and guidance,
ICH guidelines, Ultragenyx policies, SOPs and industry best
practices.Support and endorse completion of regulatory requirements
and expectations for manufacturing network.Represent CMC QA at
various forums May participate in external collaborations to
influence policy, practices and current guidance for the
manufacture of biologics, small molecules and novel
therapeutics.May act as deputy of Quality in governance bodies
making decisions on product and material specifications.Other
duties as assigned.Requirements: Level commiserate with
experience.Bachelor---s degree or equivalent work experience in QA
Manufacturing Operations or related discipline. 10 years of
experience in a GMP biopharmaceutical manufacturing environment in
technical operations and/or quality. Demonstrated ability to lead,
participate and successfully complete continuous improvement
projects, applying concepts such as project management, lean,
6-sigmaProficient in root cause analysis tools.Experience using and
facilitating use of risk management tools (FMEA, PHA, etc.)Ability
to develop CMC QA vision and mission. Constantly inspires team to
realize department vision and mission.Demonstrate quality mindset
and influences across the entire organization.Understanding of
unique quality and manufacturing expectations from other regulatory
authorities such as EMA, ANVISA, MHRA, etc.Expert knowledge of
cGMPs. Knowledge and experience negotiating quality agreements.
Flexibility and the ability to manage change.Strong interpersonal
skills and the ability to work well as part of a team.Demonstrated
ability for analytical and systematic thinking.20%
TravelLI-CV1Ultragenyx 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
talentacquisitionultragenyx.com. For electronic email and mail
inquiries, please include a description of your requested
accommodation, your name and contact information.See our CCPA
Employee and Applicant Privacy Notice.See our Privacy Policy.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:
talentacquisitionultragenyx.com.Novato, CA or Brisbane, CA
/Ultragenyx --- Quality /Full-time
Keywords: Ultragenyx Pharmaceuticals, Novato , Associate Director / Director, CMC QA, Executive , Novato, California
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