Back to jobs
New

Head of Quality (Vice President)

Cambridge, MA

Title:                   Head of Quality (Vice President)

Location:           Cambridge, MA (hybrid) 

Reports to:        Chief Operating Officer

 

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead asset is a potential first-in-class oral therapy, VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

Vedanta Biosciences is looking for an experienced Head of Quality to lead the Quality Assurance (QA), Quality Control (QC), and Clinical Quality Assurance (CQA) functions. The ideal candidate will lead a multi-faceted team of Quality professionals and deliver phase-appropriate GXP Quality guidance for Vedanta’s lead asset, VE303. In particular, the Head of Quality should have experience leading an organization through the maturation of early-phase development into later-phase and commercial programs.

The successful candidate will oversee clinical trial and product compliance globally by managing and improving existing quality systems and ensuring appropriate controls for Vedanta’s in-house cGMP manufacturing capabilities and internal QC testing. This includes expanding the existing Quality Management System (QMS), development of documents, training of personnel, and quality oversight of Live Biotherapeutic Product (LBP) manufacturing.

Vedanta uses third-party vendors for analytics and final fill/finish manufacturing; the Head of Quality will handle QA aspects of these vendors through site audits, establishment of Quality Agreements, major deviation review, and batch disposition/release. Additionally, the Head of Quality will oversee and guide QC personnel responsible for both internal and external analytical testing for Drug Substance / Drug Product release, stability, and product characterization.

As VE303 advances toward commercial readiness, the Head of Quality will lead process validation activities, including planning and execution of Process Performance Qualification (PPQ) batches. The Head of Quality will also collaborate with a Qualified Person (QP), ensuring compliance with EU GMP requirements.  The Head of Quality will manage PAI and BIMO inspection readiness and QA support of post-approval pharmacovigilance systems. Knowledge of computerized system validation and Annex 11/Part 11 is critical to success in the role.

Here’s What You’ll Do:

  • Ensure products, procedures, and practices meet Vedanta's goals, and all quality and regulatory standards
  • Facilitate risk-based decision-making, highlighting best practices and approaches while maintaining a consultative and collaborative approach
  • Manage, develop, and build the Quality team and its capabilities
  • Take an active mentorship role in developing the Quality team to best serve the business
  • Set short-term and long-term goals that are aligned with Vedanta’s corporate and quality goals
  • Actively survey and share information on changing regulations and practices that relate to Vedanta’s business
  • Collaborate with executive and functional leaders to ensure understanding and adherence to company and Quality Policies, Guidelines, Programs, and Systems
  • Provide expertise and guidance in interpreting government regulations and guidelines (such as FDA, EMA, and ICH) as they apply to products, procedures, and practices
  • Assess and make recommendations to ensure the availability of quality resources to staff the Quality efforts required to ensure both compliance with applicable regulations and support of corporate goals
  • Establish cooperative relationships with Contract Manufacturing Organizations, parent and affiliate organizations, and internal departments to improve overall quality
  • Report on Key Performance Indicators and make improvements and adjustments as indicated by changes in trends
  • Lead the expansion of the QMS, including strategic implementation of electronic systems to support internal CGMP capabilities for our LBPs
  • Support development and maintenance of operating and capital expense budgets
  • Ensure timelines are met, and costs remain within the established budgets
  • Drive the use of strategies, technologies, resources, and processes in support of quality initiatives

Requirements:

  • BS/MS in a relevant scientific discipline (e.g., Microbiology, Biochemistry) and 15+ years of relevant professional experience
  • 10+ years of experience in Quality Management with several years in a biotherapeutics manufacturing setting
  • Deep knowledge of cGXP requirements, with an understanding of phase-appropriate clinical and commercial expectations
  • Experience with FDA, QP, BIMO, and EMA/MHRA inspections and audits
  • Experience directly supporting on-site production, including responsibility for product disposition
  • A proven track record of leadership, people management, and effective interpersonal and communication skills
  • Ability to prioritize and manage through complex processes/projects
  • Experience in smaller organizations, supporting the development of novel biopharmaceutical technologies and/or products to support creative problem-solving 
  • A “can-do” attitude with a focus on team success, both within Quality and with cross-functional business partners
  • Some technical knowledge of biologics manufacturing areas, with aptitude to understand the basic science of Vedanta’s production processes
  • Demonstrated understanding of, and forward-looking vision for, the application of artificial intelligence (AI) tools within a quality organization

The base pay range for this position is expected to be $275,000 - $315,000 annually; however, the base pay offered may vary depending on market dynamics, experience, internal equity, and job-related knowledge, skills, and capabilities. The total compensation package for this position also includes stock options, a target annual bonus, and benefits.

Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

Create a Job Alert

Interested in building your career at Vedanta Biosciences? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...

If you'll require the company to commence ("sponsor") an immigration or work permit case in order to employ you, either now or at some point in the future, then you should select Yes. Otherwise, select No.

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 hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

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

Select...
Select...
Race & Ethnicity Definitions

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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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 04/30/2026

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
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.