Manager / Senior Manager, Quality | Revolo Biotherapeutics

Manager / Senior Manager, Quality

Schedule: Full-time
Location: Remote
Reports to: Director, Quality

Who we are:

If you’re looking for a typical biotechnology company, you’ve come to the wrong place.

We are a revolutionary biotherapeutics company and our mission is to revolutionize autoimmune and allergic disease treatment by resetting the immune system for superior long-term disease remission.

How?

By developing therapies that achieve superior long-term disease remission from less frequent chronic dosing and without suppression of the immune system. A goal that others haven’t been able to reach.

Why?

Existing therapies for autoimmune and allergic diseases require frequent chronic dosing, provide only short-term disease remission in a limited number of patients and suppress the immune system, ultimately putting patients at risk of developing serious infections and life-threatening side effects.

How you’ll contribute:

Reporting to the Senior Director of CMC, the Manager/Senior Manager, Clinical Supply will help lead and manage the Reporting to the ­­­Director, Quality this position plays an essential role in the development, implementation, and maintenance of the quality management system. The Manager/Senior Manager, Quality serves as the lead Quality representative for document management and training processes.  It will support the successful implementation of the electronic quality management system (eQMS).  The position works collaboratively across Revolo to ensure that research and development activities are performed in compliance with regulatory requirements and meet business needs.

Principal Duties and Responsibilities:

  • Support the development, implementation, and maintenance of a phase-appropriate quality management system.
  • Manage the day-to-day document control and training activities including maintenance of the electronic quality management system (eQMS).
  • Author, review and approve quality-related documents.  Processes to promote, facilitate and ensure compliance with regulatory and internal requirements (e.g., document templates, protocols, reports, deviations, master batch records, training materials).  Manage and assist in maintaining documentation through its retention period.
  • Coordinate and deliver training across the organization for documents and processes that support the eQMS.  Work with functional areas to establish training curricula.
  • Serve as the system administrator for the eQMS.  Support system upgrades and revalidation activities, as needed. Train users and ensure any issues are resolved in a timely and compliant manner.
  • Track, trend and monitor quality metrics. Prepare reports for management review.
  • Disposition drug substance and drug products to support GxP regulated development activities.
  • Support management to prepare, conduct, and perform follow-up activities associated with audits and regulatory inspections.
  • Collaborate with management to establish and facilitate the achievement of quality objectives and drive continuous improvement.
  • Other responsibilities as required to achieve corporate objectives.

Minimum Education, Training, and Experience Required:

  • Bachelor’s degree with 5 years of experience working in biotechnology, biologic, or pharmaceutical industries, with at least 3 years in Quality Assurance.
  • Working knowledge of regulations for Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
  • Proficient working with quality systems, particularly associated with document control, training, batch review and disposition, and deviation management.
  • Experience using electronic quality management systems is highly preferred, especially MasterControl.
  • Knowledge of manufacturing, packaging, and laboratory operations.
  • Strong interpersonal, communication (verbal and written), and organizational skills.
  • Strong attention to detail.
  • Self-motivated, able to work independently to drive quality initiatives, but committed to a team-oriented approach.
  • Flexibility to learn and apply new processes and tools.

This position requires extended periods of sitting and working on a computer. Must have the ability to navigate domestic travel.

Revolo Biotherapeutics is an Equal Opportunity/Affirmative Action Employer – EOE Minorities/ Females / Protected Veterans / Individuals with Disabilities.

Please send your resume and cover letter to cvincent@revolobio.com

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Glen Giovanetti

Non-Executive Director

Glen Giovanetti has more than 35 years of experience in strategy and operational leadership in the life science industry as well as in financial governance, risk and reporting as EY’s Global Biotechnology Sector Leader and Life Sciences Sector Leader. He currently serves on the Board of Directors of Life Science Cares, Teon Therapeutics and XW Pharma.

Marla S. Persky

Non-Executive Director

Marla S. Persky currently serves as the chief executive officer and president of WOMN LLC. She has more than 25 years of international senior business and legal experience in the pharmaceutical industry having held numerous business and legal positions at Boehringer Ingelheim and Baxter International. She currently serves on the Boards of Directors of Xeris Pharmaceuticals, YGEIA Consulting Group, Primary Stages, World Neighbors and A Better Chance in Ridgefield.

Dora Rau

Senior Vice President, Quality

Dora Rau brings 25 years of experience in development and commercial operations for drugs, biologics, devices and combination products to the team. She has held numerous executive-level quality positions, with expertise in building quality systems and in leading teams to attain successful regulatory authority inspection outcomes and product approvals.

Jonathan Gold

Chief Financial Officer

Over the last 25 years, Jonathan Gold has been an institutional venture capitalist, a public fund manager, a founder, an operating executive, and a board member for companies across sectors including life sciences. In those roles, he was active in the development, financing and mergers and acquisitions for numerous public and private companies.

Team Members

Michael Albisser

Non-Executive Director​

Michael is a partner of Metellus, a Zurich and London-based venture capital firm investing in technology and life sciences with ground-breaking potential. Having more than 25 years of experience in the finance area he is responsible for finance, tax, and deal structures. He serves on the board of various venture-backed companies.

Dr. Isaac Cheng, m.d.

Non-Executive Director

Dr. Isaac Cheng is currently an investment professional at Morningside, a venture capital and private equity institution based in Boston USA, and Shanghai China. Dr. Cheng focuses primarily on biopharmaceutical and healthcare investments. He has served on numerous public and private company boards.

Peter Greenleaf

Chairman

Peter Greenleaf currently serves as the chief executive officer (CEO) and member of the Board of Directors of Aurinia, (NASDAQ: AUPH / TSX: AUP), an autoimmune therapeutics company. He has held several other CEO and chairman roles. He is also currently a member of the Board of Directors of Antares Pharmaceuticals, Inc. (NASDAQ: ATRS) and Chairman of the Board of Directors of Biodelivery Sciences International, Inc. (NASDAQ: BDSI).

Marylyn Rigby

VP of Marketing and Investor Relations

Marylyn Rigby is an experienced pharmaceutical, biotech, and drug delivery professional. In addition to her expertise in marketing, public and investor relations, she has a successful track record with business development, licensing, public and private equity financing, strategy and other key corporate functions.

Nancy Vinh

VP of Clinical Operations

Nancy Vinh brings over 20 years of experience in managing early and late phase, international clinical trials for drugs, biologics, cell therapy and combination products across a wide range of therapeutic areas to the team. She has served as head of clinical operations and led registrational and label expansion trials execution.

Team Members

Dr. Clare Burgess

Chief Development Officer

Dr. Clare Burgess has 24 years of experience in clinical drug development as a pharmacologist and has worked across a wide range of therapeutic areas within the pharmaceutical industry. She has held multiple leadership roles and has led multidisciplinary teams across the world.

Jeff Myers, m.d., ph.d

Chief Medical Officer

Jeff Myers, M.D., Ph.D., has 20 years of experience in medical affairs, regulatory and clinical development within the biopharmaceutical industry, with focuses on cardiovascular, pulmonary, oncology, and inflammatory diseases.

Before entering the industry, he practiced as a congenital cardiac surgeon and served as the chief of pediatric cardiac surgery at Massachusetts General Hospital and as Associate Professor of Surgery at Harvard Medical School.

Team Members

Dr. Roly Foulkes

Chief Scientific Officer

A true drug discoverer, Dr. Roly Foulkes has 25 years of experience building and delivering innovative therapeutic portfolios within the immunology and inflammatory disease space. He has a strong record advising small and medium sized immunology biopharma companies in developing competitive therapeutic strategies and bringing new innovative molecules to the clinic.

Team Members

Jones w (woody) Bryan, ph.d.

Chief Business Officer

Jones (Woody) Bryan, Ph.D., brings almost 30 years of experience in the healthcare industry to the team, having led successful business development operations in both private and public pharma and biotech companies.

Team Members

Perry Calias, ph.d.

Chief Operating Officer

Perry Calias, Ph.D., brings over 25 years of experience in pre-clinical and clinical development, CMC and global regulatory submissions across the drug and device sectors of healthcare. He has held numerous executive positions leading clinical and non-clinical operations, with a strong focus on diseases of the central nervous system and rare diseases.

Team Members

Jonathan Rigby, mba

Group Chief Executive Officer

As employee #1 of Revolo Biotherapeutics in the US, Jonathan Rigby has led the company through substantial and rapid growth. He brings three decades of experience creating value and opportunities for companies in the pharmaceutical, biotech and drug delivery technology industry.

Team Members
  • Carrie Vincent: Director, HR & Senior Executive Administration
  • Dr. Jones W. (Woody) Bryan: Chief Business Officer
  • Dr. Roly Foulkes: Chief Scientific Officer
  • Jonathan Gold: Chief Financial Officer
  • Jeff Myers, MD: Chief Medical Officer
  • Marylyn Rigby: VP Marketing & Investor Relations
  • Dr. Perry Calias: Chief Operating Officer