Manager, QA Supplier Management

Title:                   Manager, QA Supplier Management

Location:           Cambridge, MA

Reports to:        Director, QA Compliance

The Role:

This individual is responsible for managing Vedanta’s GMP Supplier Management and Auditing Programs to ensure that suppliers of GMP materials and services and Vedanta’s internal GMP operations are qualified for use and operating according to CGMP regulations, ICH guidelines, 21CFR 210, 211 and Part 11, and our internal procedures. This role will work with program teams and functions to identify new suppliers, follow up on supplier corrective actions, and improve the supplier qualification process. Additionally, they will establish and conduct the annual internal audit program and work with teams to close compliance gaps. This individual will track and communicate compliance to functional heads, senior management, and external partners.

Here’s What You’ll Do:

• Manage the Supplier Qualification program - developing annual plans, setting up audits, maintaining documentation, and initiating and follow-up of compliance issues. This includes maintaining the list of qualified vendors, maintaining the master audit schedule, establishing the need for Quality Agreements, and follow through of issues identified at vendors.
• Manage and review the Supplier Change Notifications and Supplier Corrective Action processes.
• Develop and report periodic metrics to measure the status of the Supplier Management System and ensure that suppliers continue to maintain a Quality level of service for Vedanta.
• Maintain records and SOPs for Supplier Lifecycle and Supplier Audits and align with GMP requirements.
• Manage the internal auditing program - establishing the annual plan and audit questionnaires per functional area and GMP requirements. Identify and train a team of internal auditors, conduct timely follow up correction and improvements.
• Establish a regular schedule of reporting Supplier quality metrics to QA, to the functional areas and to senior management to endure ongoing compliance to GMPs.

Requirements:

• BS in Life Sciences with minimum 5 years in a pharmaceutical biotechnology environment.
• 5 years in a Quality Assurance role with 3 years managing supplier qualification and auditing.
• Proficiency in application of FDA 21CFR 211 and Part 11, ICH Guidelines, EU GMP regulations to supplier quality requirements.
• Demonstrated ability to meet timelines and achieve results in a team environment.
• Have basic knowledge of drug development process, knowledge CGMP/GDP agency regulations (e.g., FDA, EMA, Health Canada, ICH), and ability to apply standards appropriately to situations.
• Past participation in regulatory inspections or audits a plus.
• Excellent verbal and written skills, allowing for an open and effective dialogue between departments and clear communication to senior management on status and program needs.
• Ability to work independently and think strategically to improve current processes.
• Personal Competencies: self-awareness, integrity, problem analysis, communication, risk management.
• Interpersonal skills: team and consensus building, effective meeting management
• Ability to travel to suppliers for audits (approximately 30%)

Why join Vedanta Biosciences

Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

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.