NovatoRecruiter Since 2001
the smart solution for Novato jobs

Associate Director / Director, CMC QA

Company: Ultragenyx Pharmaceuticals
Location: Novato
Posted on: January 13, 2021

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 skills and experience.Bachelor---s degree preferably in an Engineering, Biotechnology, Biological/Physical sciences, or equivalent.ASSOCIATE DIRECTOR: 8 years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality.DIRECTOR: 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% Travel domestic and internationalLI-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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Resident Care Director - LVN
Description: - : Get ready to experience a luxury senior living experience, partnered with top-notch care, at Elegance at Novato Our community will offer Assisted Living and Memory Support services.Overview: Now (more...)
Company: Elegance at Novato Assisted Living and Memory Care
Location: Novato
Posted on: 01/16/2021

Maintenance Manager
Description: br br Dollar General Corporation has been delivering value to shoppers for more than 80 years. Dollar General helps shoppers Save time. Save money. Every day by offering products that are frequently (more...)
Company: Dollar General
Location: West Sacramento
Posted on: 01/16/2021

Internet Sales Director
Description: Marin Honda is looking for an experienced Internet Sales Director to join our team and help deliver extraordinary customer experiences. JOIN OUR TEAMPenske Automotive Group PAG is the second largest (more...)
Company: Marin Honda
Location: San Rafael
Posted on: 01/16/2021


Community Development Director
Description: COMMUNITY DEVELOPMENT DIRECTORCITY OF SAN RAFAEL, CALIFORNIA 156, 336 --- 190,032 annually DOQ/DOECome join our boundary-pushing and transformative Executive Team at the City of San RafaelThe City of (more...)
Company: Government Jobs
Location: San Rafael
Posted on: 01/16/2021

Refinery General Manager
Description: Position Description: The OpportunitySafety-Kleen, Newark, CA is looking for a Refinery General Manager to join their safety conscious team Why work for Safety-Kleen Health and Safety is our 1 priority (more...)
Company: Safety-Kleen
Location: Newark
Posted on: 01/16/2021

Sr Director, Human Resources Business Partnership
Description: DescriptionThe Opportunity The Sr Director, Human Resources Business Partnership will lead the global HR Business Partner team to deliver exceptional support to our corporate functions and help evolve (more...)
Company: Rodan & Fields
Location: San Ramon
Posted on: 01/16/2021

Director - Programs for People with Developmental Disabilities
Description: Location: Santa Cruz, CATeam: Program Management - Program Management Team /Work Type: Full-Time br br Are you seeking fulfilling work that gives you the opportunity to make a difference in the lives (more...)
Company: Hope Services
Location: Santa Cruz
Posted on: 01/16/2021

Human Resources Manager
Description: Apply Now Posted : July 29, 2020 Job Type : Permanent Category : ManufacturingDescriptionLarge
Company: The Judge Group
Location: Petaluma
Posted on: 01/16/2021

Services Manager (Beauty/Cosmetology)
Description: OVERVIEWExperience a perfect blend of deliberate purpose and clear-eyed vision. At Ulta Beauty, some of the industry's most highly-esteemed beauty leaders share themselves, as well as their expertise. (more...)
Company: Ulta Beauty
Location: Gilroy
Posted on: 01/16/2021

Manager OSP Engineering Design (PB)
Description: Working as a Manager of Outside Planning Design, you will be responsible for the planning, design and analysis of the outside plant facilities/network in an individual contributor role. You will perform (more...)
Company: Regular
Location: San Ramon
Posted on: 01/16/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Novato RSS job feeds