Senior Manager, Quality Control Operations

3 weeks ago

Woburn, Massachusetts, United States Ultragenyx Full time

Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.


Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Reporting to the Director, Quality Control Operations, the Senior Manager, QC Operations and Stability will perform quality control functions supporting drug substance, drug product and cell banks. This individual with collaborate with cross functional stakeholders and externally with contract manufacturing facilities.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

  • Evaluate product stability data to establish and extend product shelf-life.
  • Assure ongoing readiness for regulatory inspection; participate in audits and inspections.
  • Create and improve procedures.
  • Support Regulatory submissions (e.g, INDs, BLAs), coordinate data requests, compilation and management of externally generated data
  • Ensures appropriate data integrity controls/ALCOA/data integrity issues for system requirements.
  • Generation of Certificate of Analysis
  • Serve as a technical lead for management of Quality Records: Global application of root cause, deviations, impact assessments, complex investigations in collaboration with other departments.
  • Provide hands-on leadership for the QC Operations oversight of the group, data review, schedule and training.
  • Provide oversight and support to contingent staff on site

Requirements:

  • BS in Biology, Biochemistry, Chemistry or equivalent are of study/discipline
  • 7+ years of GMP experience in Pharmaceutical Industry
  • Experience in data management, LIMS experience preferred
  • Organized and skilled in managing multiple responsibilities, priorities, tasks and projects simultaneously
  • Strong interpersonal skills that include negotiation, active listening, and relationship management
  • Comfortable with interfacing effectively across all levels and organizations
  • Independently motivated and detail-oriented with good critical thinking, problem-solving ability, and analytical skills #LI-CS1 #LI-Onsite

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

· Generous vacation time and public holidays observed by the company

· Volunteer days

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Employee wellbeing benefits

· Fitness reimbursement

· Tuition sponsoring

· Professional development plans

* Benefits vary by region and country


Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at


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: .

  • Senior Quality Engineer

    4 weeks ago

    Woburn, Massachusetts, United States SES AI Corp Full time

    Senior Quality Engineer About UsSES is a global leader in development and production of high-performance Li-Metal rechargeable batteries for electric vehicles (EVs) and other applications. Founded in 2012, SES is an integrated Li-Metal battery manufacturer with strong capabilities in material, cell, module, AI-powered safety algorithms and recycling....

  • Senior Project Manager

    4 weeks ago

    Woburn, Massachusetts, United States SES AI Corp Full time

    Senior Project ManagerPosition ScopeSES is seeking a talented Senior Project Manager to join our team. The successful candidate is committed and dedicated, responsible, focused, detail-oriented, able to adjust in a fast-paced working environment, collaborate well with other staff members with a shared vision and demonstrate excellent organizational...

  • Pharmacy Quality Improvement Specialist

    3 weeks ago

    Woburn, Massachusetts, United States Elevance Health Full time

    Pharmacy Quality Improvement Specialist Location: This position will work a hybrid model (remote and office). Ideal candidates will live within 50 miles of one of our PulsePoint locations. A proud member of the Elevance Health family of companies, CarelonRx leverages the power of new technologies and a strong, clinical-first lens, to deliver member-centered,...

  • Senior Accountant

    1 day ago

    Woburn, Massachusetts, United States American Tower Corporation Full time

    The TeamWe are seeking a Senior Accountant to join American Tower's U.S. Tower division's Finance organization. The Accounting team within the Finance organization properly records and reports the Company's U.S. Tower division's revenue and direct expenses for both the tower and managed networks businesses. The Accounting team also supports operational teams...

  • Marketing Operations Associate

    1 day ago

    Woburn, Massachusetts, United States Sirtex Medical Limited Full time

    Job DescriptionJob Function: Provide overall support to the Global Marketing Team with a focus on the Americas Region. This support will consist of Marketing Operations duties.RESPONSIBILITIES / AUTHORITIES:Marketing Operations Support:Process vendor invoices for US projects and manage vendor spending tracker.Support Senior Marketing Operations Manager with...

  • Senior Corporate Development Analyst

    1 day ago

    Woburn, Massachusetts, United States American Tower Corporation Full time

    The TeamWe're seeking a Senior Corporate Development Analyst to join American Tower's Corporate Development, Mergers & Acquisition, and Property Management team. The team fuels growth through value additive acquisitions, investments, partnerships, and other development opportunities. This position's primary goal is to assist with evaluating and analyzing...

  • Behavioral Health HEDIS Quality Program Manager

    3 weeks ago

    Woburn, Massachusetts, United States Elevance Health Full time

    Location: Within 50 miles of one of our Eastern Time Zone Elevance Health Pulse Points Shift: Monday - Friday; 8:00am - 5:00pm ET The Behavioral Health HEDIS Quality Program Manager is responsible for serving as the quality lead and overseeing the quality improvement activities/projects/programs for one or more health plans within a major line of business....

  • Audit Senior

    2 days ago

    Woburn, Massachusetts, United States Withum Full time

    Withum is a forward-thinking, technology-driven advisory and accounting firm, helping clients to Be in a Position of StrengthSM in today's modern business landscape. Withum empowers clients with innovative tools and solutions to address their accounting, tax and overall business management needs. Withum is a place where talent thrives. We recruit only the...

  • Assistant Store Manager

    1 day ago

    Woburn, Massachusetts, United States CHICO'S Full time

    Join our chic team, dedicated to a styling and social experience that inspires women to express their individuality.POSITION OBJECTIVE:The Assistant Store Manager is responsible for supporting the Store Manager in promoting a customer and product-focused sales culture, where our values and guiding principles are at the forefront of all store operations,...

  • Construction Project Manager

    2 days ago

    Woburn, Massachusetts, United States Michael Page Full time

    About Our Client Our client has been in business for more than three decades. They pride themselves on having a great market reputation and have a large amount of repeat business. With a full pipeline heading into 2024 they are looking to add a skilled Project Manager to their team. The projects range in size and scope and can be anything from a small...

  • Construction Project Manager

    1 day ago

    Woburn, Massachusetts, United States Michael Page Full time

    About Our Client Our client has been in business for more than three decades. They pride themselves on having a great market reputation and have a large amount of repeat business. With a full pipeline heading into 2024 they are looking to add a Superintendent to their team. Job Description As the Construction Project Manager, you will:Establish the project...

  • Head of Operations, VP

    1 week ago

    Woburn, Massachusetts, United States Northern Bank Full time

    At Northern Bank, banking may be our business, but helping small businesses grow is our passion. Right now, we are looking for a Head of Operations who understands the vital role the Operations Team plays in ensuring our clients have an exceptional customer experience. In this role, you will provide leadership and oversight for the Operations Department as...

  • IP Manager

    4 weeks ago

    Woburn, Massachusetts, United States SES AI Corp Full time

    IP Manager Position Scope SES is seeking a talented IP Manager to join our team. The successful candidate is committed and dedicated, responsible, focused, detail-oriented, able to adjust in a fast-paced working environment, collaborate well with other staff members with a shared vision and demonstrate excellent organizational communication skills. The right...

  • Forklift Operator

    1 day ago

    Woburn, Massachusetts, United States Randstad USA Full time

    As an pallet jack operator, you will unload materials and merchandise from incoming vehicles and load them onto assigned locations. You will also locate and move products on pallets or create pallets for storage or shipment and identify damages and report shortages or quality deficiencies. (WALKIE RIDER) Equal Opportunity Employer: Race, Color, Religion,...

  • Residential Counselor Multiple Schedules Available

    1 day ago

    Woburn, Massachusetts, United States IAP Worldwide Services, Inc Full time

    The COMBS Site Manager manages, plans, directs, controls, coordinates and evaluates all logistics and personnel management functions at Contractor Operated and Maintained Based Supply (COMBS) sitesEssential Job Functions:• Manages personnel in Supply, Logistics, Warehouse, etc. to ensure timely and accurate COMBS management.• Supervises the transfer,...

  • Director, Finance Americas

    1 day ago

    Woburn, Massachusetts, United States Sirtex Medical Full time

    Company DescriptionSirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with...

  • Program Manager, Sensors Development

    1 day ago

    Woburn, Massachusetts, United States STR Full time

    About the TeamThe Sensors Division at STR focuses on applied research and advanced technology development on innovative sensor system technology, from underwater acoustics and active/passive EO/IR to radar and electronic warfare. Our work spans the modeling, development, integration, and test and evaluation required to prove the capability at each step.The...

  • Full Time Patient Care Monitor/Greeter

    3 weeks ago

    Woburn, Massachusetts, United States BayMark Health Services Full time

    Full Time Patient Care Monitor/Greeter Health Care Resource Center is looking for a respectful, alert and vigilant greeter/ patient care monitor to maintain overall safety and order of the clinic facility. The greeter/patient care monitor may also provide backup coverage to receptionist. Essential Duties & Responsibilities: Ensuring the protection of all...

  • Warehouse Associate

    2 days ago

    Woburn, Massachusetts, United States Trane Technologies Full time

    At Trane TechnologiesTM and through our businesses including Trane and Thermo King, we create innovative climate solutions for buildings, homes, and transportation that challenge what's possible for a sustainable world. We're a team that dares to look at the world's challenges and see impactful possibilities. We believe in a better future when we uplift...

  • Security Applications Engineer

    1 day ago

    Woburn, Massachusetts, United States BCM Controls Corporation Full time

    Who we are: At BCM Controls, we are focused on our people, our culture, and our business. Our goal is to be the "Best Place You Will Ever Work" We are growing and looking to hire great people to support our vision. BCM specializes in building automation, security systems and energy services for commercial, institutional, and industrial clientele. There is no...