Senior Manager, Assurance

Rubius Therapeutics is a clinical-stage biopharmaceutical company that is generating red blood cells and engineering them into an entirely new class of allogeneic, off-the-shelf cellular medicines. Our Red Cell Therapeutics can potentially be used to replace missing enzymes for patients living with rare enzyme deficiencies, kill tumors in cancer and regulate the immune system for the treatment of autoimmune diseases. We expect to begin enrolling patients in our first clinical trial during the second quarter of 2019, which is evaluating RTX-134 for the treatment of phenylketonuria, an inherited metabolic disorder. Additionally, we plan to file our first oncology IND for RTX-240 for the treatment of solid tumors by early 2020. In total, we plan to file four to five INDs during 2019 and 2020.

We are proud of our passionate, high-performance culture one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are based in Cambridge, MA and currently expanding across all functions within the organization. Having completed our initial public offering in July 2018, (Nasdaq: RUBY), we are well capitalized to execute our vision of creating life-changing cellular medicines. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn.

Summary

As a key member of the Quality team, the Sr. Manager Assurance is recognized as an expert internally in the principles and application of quality assurance and compliance related to product disposition. The Sr. Manager Assurance coordinates GMP activities in support of clinical Drug Product disposition for intermediate, drug substance and drug product manufactured and tested externally at CMOs. The Sr. Quality Specialist demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices ensuring alignment with all regulatory requirements.

We're looking for someone that understands "phase appropriate", isn't afraid to take risk, and will roll-up their sleeves and get a little dirty. This role expected to embrace Rubius's values; we are inventive, we have integrity, we are inclusive, we have courage and we work with urgency. Diversity of thoughts, experiences and backgrounds make us stronger, so ability to listen, debate and collaborate is a must. And last, but not least, we insist on having fun on this journey.

Responsibilities

• Product Release/Documentation Review

• Responsible for clinical batch disposition, review and quality oversight of CMOs. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.

• Responsible for review/approval of clinical lot COAs, generating BSE/TSE statement and product labelling as applicable.

• Responsible for archival of batch records and other supporting documents in eDOC system.

• Responsible for generating performance metrics, trends related to CMO quality oversight

• Review and approval of product stability and reference standard data

• Review drug product temperature excursions for Clinical Trial Material

• Liaise with key stakeholders to ensure only approve vendors are used in support of GxP operations

• Quality Systems Support

• Review and approve SOPs and specifications as needed

• Provide QA support of quality events, quality risk assessment, change controls, investigations (OOS, OOT), associated RCA, CAPAs and effectiveness checks.

• Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.

• Participate in product compliant investigations and recalls as necessary.

• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.

• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.

• Audit / Inspection Support

• Participate in inspection readiness activities and provide support during regulatory site inspections (as necessary).

• Perform vendor cGMP audits as needed

• Develop and deliver regulatory training

• GLP/Laboratory

• Assist as needed with review and/or audits of laboratory documents such as protocols, study reports, and regulatory submission documents

• Assist as needed with GCP/GLP vendor assessments

Qualifications & Education

• Bachelor's or Master's degree in Biology, Chemistry, Engineering or Life Sciences

• Laboratory experience preferred

• Experience in cGMP manufacturing environment (at least 3 years)

• Knowledge of cGMP Regulations for Ph I III clinical trials (FDA & International)

• Experience in reviewing batch records, product disposition and product labelling

• Experience in supporting laboratory investigations, conducting risk assessment, root cause analysis, CAPAs

• Experience and interactions with Contract Manufacturing Organizations

• Excellent organizational skills, attention to detail, written and verbal communication skills

• Demonstrated success in collaborating with cross functional teams

• cGMP vendor auditing experience preferred

• Experience in gene/cellular therapies a preferred

• Experience with Veeva and eQMS a plus

• Ability to Travel (approximately 25%)

EEO Statement: Rubius Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Recruitment & staffing agencies: Rubius Therapeutics does not accept agency resumes unless contacted directly by internal Rubius Talent Acquisition. Please do not forward resumes to our careers@rubiustx.com account, Rubius employees or any other company location; Rubius Therapeutics is not responsible for any fees related to unsolicited resumes.