Senior Specialist, QA Operations (Temporary)

Vir Biotechnology; San Francisco (CA); On-site; USD 72,000 - 96,000; Full time

Job summary

Vir Biotechnology, Inc. is seeking a Temporary Senior Specialist, Quality Operations to support quality oversight across manufacturing, testing, packaging, and labeling at Vir and CMOs/CTLs.

You will help ensure products are manufactured, tested, and released in compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. You will contribute to quality review and approval activities, support issue management and investigations, and help maintain quality

Qualifications

• Bachelor's degree in a scientific discipline with 5+ years of QA/QA Ops experience preferred.
• Experience supporting GMP manufacturing and testing activities.
• Familiarity with deviations, CAPAs, change controls, investigations and document management.

Responsibilities

• Support quality oversight of manufacturing, testing, packaging and labeling activities by CMOs/CTLs and suppliers.
• Review quality records, deviations, CAPAs, change controls, investigations and SOPs.
• Review batch records and release documentation for manufacturing and testing.
• Support batch disposition and release activities.
• Review validation protocols and reports (process, method, cleaning).
• Collaborate with cross- functional teams to address quality issues and support operations.
• Assist with supplier quality management and Quality Agreement maintenance.
• Support internal and supplier audits and regulatory inspection readiness.
• Escalate quality issues and compliance risks to management as appropriate.
• Contribute to continuous improvement initiatives within Quality.

Skills

Quality Assurance

GMP compliance

Quality Operations

Documentation management

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Job description

Senior Specialist, QA Operations (Temporary)

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN ® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Vir Biotechnology has exclusive rights to the universal PRO-XTEN ® masking platform for oncology and infectious disease. PRO-XTEN ® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

THE OPPORTUNITY

Vir Bio is looking for a Temporary Senior Specialist, Quality Operations (12+ Month Initial Contract) who will support quality oversight activities related to manufacturing, testing, packaging, and labeling operations at Vir Biotechnology and Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and suppliers. This individual will partner with cross-functional teams to help ensure products are manufactured, tested, and released in compliance with current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements.

You will contribute to quality review and approval activities, support issue management and investigations, and help maintain quality systems that support clinical and commercial products across our development portfolio.

This role is based in our San Francisco, California office with the expectation to be onsite three days per week.

WHAT YOU'LL DO

• Support quality oversight of manufacturing, testing, packaging, and labeling activities performed by CMOs, CTLs, and suppliers
• Review quality records including deviations, CAPAs, change controls, investigations, and SOPs
• Review manufacturing and testing documentation, including batch records and supporting release documentation
• Support batch disposition and release activities
• Review validation protocols and reports, including process, method, and cleaning validation activities
• Collaborate with cross-functional teams to address quality issues and support ongoing operations
• Assist with supplier quality management activities and Quality Agreement maintenance
• Support internal audits, supplier audits, and regulatory inspection readiness activities
• Escalate quality issues and compliance risks to management as appropriate
• Contribute to continuous improvement initiatives within the Quality organization

WHO YOU ARE AND WHAT YOU BRING

• Bachelor's degree in a scientific discipline and 5+ years of experience in Quality Assurance, Quality Operations, Manufacturing, or a related GMP-regulated pharmaceutical or biotechnology environment preferred
• Experience supporting GMP manufacturing and testing activities
• Familiarity with quality systems including deviations, CAPAs, change controls, investigations, and document management
• Working knowledge of cGMP regulations and quality principles
• Strong organizational, communication, and collaboration skills
• Experience working with CMOs, CTLs, or suppliers preferred

WHO WE ARE AND WHAT WE OFFER

The expected hourly range for this position is $52.00 to $70.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, Vir Biotechnology, participates in E-Verify .

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Vir Biotechnology’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your "major life activities." If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

• Alcohol or other substance use disorder (not currently using drugs illegally)
• Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heart disease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficulty hearing
• Diabetes
• Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
• Epilepsy or other seizure disorder
• Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
• Intellectual or developmental disability
• Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
• Nervous system condition, for example, migraine headaches, Parkinson's disease, multiple sclerosis (MS)
• Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
• Partial or complete paralysis (any cause)
• Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
• Short stature (dwarfism)
• Traumatic brain injury

Disability Status Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.