Senior Manager, Assurance

Rubius Therapeutics, Inc. Cambridge , MA 02138

Posted 5 months ago

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Assurance Senior Associate Stevenage UK

Tcr2 Therapeutics Inc.

Posted 3 days ago

VIEW JOBS 12/7/2019 12:00:00 AM 2020-03-06T00:00 TCR² Therapeutics Inc. is a clinical-stage immuno-oncology company developing the next generation of novel T cell therapies for patients suffering from cancer. Our proprietary TRuC™ (TCR Fusion Construct) T cells harness the natural T-cell receptor complex to recognize and kill cancer cells using the full power of T cell signaling pathways independent of HLA. TRuC-T cells have demonstrated superior anti-tumor activity in vivo compared to CAR-T cells while releasing lower levels of cytokines in preclinical studies. TCR² was founded by MPM Capital and is headquartered in Cambridge, MA to leverage best-in-class technologies and nucleate top-tier academic laboratories from around the world. TCR² has embarked on establishing a cGMP manufacturing operation in the UK at Stevenage, Hertfordshire, to provide manufacturing capacity for Phase 1 and 2 operations, and beyond, for TRuC™ T cell platform. The Quality Assurance Associate will support the manufacture and release of products under the Quality Management System environment, support product and batch record reviews, investigations into non-compliances, CAPA management, supplier qualification and documentation controls. Requirements: * Maintain quality supporting documentation to facilitate GMP production. * Perform quality review of manufacturing records. * Review Change Control records impacting T cell therapy product. * Release documents and labels to the manufacturing production teams. * Provide investigational support of potential deviations for the manufacture, testing, and shipping events to and from the UK. * Write and revise quality SOPs and associated documentation to support GMP production. * Support the quality vendor approval for suppliers, contractors and service providers. * Assist in providing training for GMP and GDP processing. * Perform deviation review and implementation of CAPA to improve product quality. * Liaison with CGT Quality department on quality related issues. Qualifications: * Bachelor's degree in the biological sciences or related field. * Minimum of 5 years GMP experience in a biotech, or biologics operation, or equivalent education/work experience. * Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS. * Prior experience in a quality function (quality assurance or quality control), preferably in a commercial environment. * Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards, preferably gained from working in a manufacturing or QC environment. * Good interpersonal, verbal and written communication skills. * Comfortable in a fast-paced small company environment with minimal direction. * Internal auditing experience preferred. Interested candidates should send their resume to careers@tcr2.com Tcr2 Therapeutics Inc. Cambridge MA

Senior Manager, Assurance

Rubius Therapeutics, Inc.