Manager/Senior Manager, Quality Assurance
Apply NowCompany: Abata Therapeutics
Location: Watertown, MA 02472
Description:
About us:
Abata has a big vision focused on translating the biology of regulatory T cells (Tregs) into transformational medicines for patients, particularly in severe autoimmune and inflammatory diseases with inadequate or no therapeutic options. While cell therapies represent a significant advancement in treating human disease, they have not yet been rigorously evaluated and developed for the treatment of autoimmune and inflammatory diseases. The company believes that by engineering Tregs for targeted activation only at the site of disease, enabling a robust, durable response, while avoiding systemic immune suppression, they can revolutionize the treatment of these challenging chronic diseases.
Our work is transformative which is why we hire the best, brightest, and most importantly...kind people. Being kind is not just a personality trait we look for, it's a core value, embedded in the way we work and how we shape your experience at Abata Therapeutics. One of the most important aspects of your experience at Abata is how you develop and grow with the company. Our culture of learning and growth enables everyone to do their best work and contribute to fulfilling our mission.
The Role:
Abata is looking for a talented Quality Assurance lead to oversee our external GMP manufacturing activities and to support our internal GxP activities and QMS system. This position will be integral in our quest to provide innovative and transformative therapies to patients. Some of the key components of this role include oversight and collaboration with our external manufacturing organization, disposition of drug product, quality event management, internal QMS management, and cross-functional QA representation on sub-functional teams.
Major Responsibilities:
Requirements and Qualifications:
We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
This is an on-site position based in the Watertown, MA office and the employee will be required to work in the office on a regular basis.
Abata Therapeutics will require compliance with our COVID- 19 vaccination policy. Please Review our conditions of employment.
Conditions of employment:
All current Abata employees have received the first two rounds of vaccinations against COVID-19. Vaccination status must be confirmed prior to any new hires joining the team. Up to date vaccination is strongly encouraged for every employee who intends to work onsite at our office and lab facility. Should an employee choose not to receive the vaccine, we will seek to understand the facts of their individual circumstance and determine if an appropriate work arrangement can be achieved.
Abata has a big vision focused on translating the biology of regulatory T cells (Tregs) into transformational medicines for patients, particularly in severe autoimmune and inflammatory diseases with inadequate or no therapeutic options. While cell therapies represent a significant advancement in treating human disease, they have not yet been rigorously evaluated and developed for the treatment of autoimmune and inflammatory diseases. The company believes that by engineering Tregs for targeted activation only at the site of disease, enabling a robust, durable response, while avoiding systemic immune suppression, they can revolutionize the treatment of these challenging chronic diseases.
Our work is transformative which is why we hire the best, brightest, and most importantly...kind people. Being kind is not just a personality trait we look for, it's a core value, embedded in the way we work and how we shape your experience at Abata Therapeutics. One of the most important aspects of your experience at Abata is how you develop and grow with the company. Our culture of learning and growth enables everyone to do their best work and contribute to fulfilling our mission.
The Role:
Abata is looking for a talented Quality Assurance lead to oversee our external GMP manufacturing activities and to support our internal GxP activities and QMS system. This position will be integral in our quest to provide innovative and transformative therapies to patients. Some of the key components of this role include oversight and collaboration with our external manufacturing organization, disposition of drug product, quality event management, internal QMS management, and cross-functional QA representation on sub-functional teams.
Major Responsibilities:
- Independently represents Quality Assurance in day-to-day interactions with contract manufacturer and internal cross-functional teams
- Reviews and approves master batch records, executed batch records, and test procedures and records.
- Dispositions drug product and supports Clinical Trial Material shipment.
- Supports investigations regarding Good Manufacturing Practice (GMP) related quality events.
- Reviews and approves deviations, CAPA, investigations, and out-of-specification investigations.
- Supports change management at contract manufacturer, and maintains/supports internal change management.
- Supports the establishment and oversight of internal translational laboratory and testing.
- Reviews and approves internal protocols and reports.
- Works cross-functionally across the organization.
- Participates in external auditing.
- Supports the establishment of an internal auditing program
- Administers the QMS system and training program.
- Effectively represents Quality Assurance, both internally and externally.
Requirements and Qualifications:
- Bachelor's degree or higher in Biology, Chemistry, Microbiology, Life Sciences, or an equivalent scientific discipline
- Experience in quality or regulatory compliance within pharmaceutical, biologics, or cell therapy manufacturing (cell therapy experience is desired)
- 5+ years Good Manufacturing Practice (GMP) experience
- Travel 0-10% (mostly local)
We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
This is an on-site position based in the Watertown, MA office and the employee will be required to work in the office on a regular basis.
Abata Therapeutics will require compliance with our COVID- 19 vaccination policy. Please Review our conditions of employment.
Conditions of employment:
All current Abata employees have received the first two rounds of vaccinations against COVID-19. Vaccination status must be confirmed prior to any new hires joining the team. Up to date vaccination is strongly encouraged for every employee who intends to work onsite at our office and lab facility. Should an employee choose not to receive the vaccine, we will seek to understand the facts of their individual circumstance and determine if an appropriate work arrangement can be achieved.