Associate Director Clinical Quality Assurance & Inspection Readiness

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

The Associate Director, GCP Quality Assurance oversees GCP activities at Rubius, our CROs and Investigator Sites, leads related vendor and site audits, and implements internal quality systems/processes for ongoing compliance and Inspection Readiness. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization and post-marketing clinical trials. This person will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams. This individual will be hands on with internal and external partners. This is a high visibility position with great impact potential.

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 is 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

  • Proactively provide GCP QA support for clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency

  • Work dynamically and proactively with other Quality Assurance and Functional Area leads to facilitate development of GXP-compliant procedures to support conduct of clinical studies and prepare the company to successfully commercialize pharmaceutical products

  • Assist with the organization, planning, preparation, coordination, and documentation of regulatory inspections, including QA oversight and auditing of eTMF.

  • Lead, and/or conduct, Good Clinical Practice (GCP) Audits of systems and processes related to clinical drug development and operations. The role also includes Good Laboratory Practice (GLP) audits related to pre-clinical studies.

  • Lead, and/or conduct/support (in collaboration with GMP QA colleagues), global Good Pharmacovigilance Practice (GVP) Audits of systems and processes related to clinical and post-market patient safety information collection, evaluation and reporting

  • Select and manage contractors who provide contract audit services

  • Lead quality investigations, including generation and follow-up of Corrective and Preventative Action (CAPA) plans

  • Lead GCP related refinements and improvements to the Quality System of controlled procedures (Policies, SOPs, Work Instructions, etc.)

  • Provide GCP compliance oversight of internal systems and processes as well as those of CROs, Vendors, and Clinical Investigator Sites (via vendor selection, vendor audits, site audits and execution of integrated clinical quality management plans)

  • Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)

  • Develop and measure quality metrics to drive consistent standards throughout the organization

  • Create key quality metrics for tracking and trending data related to GCP activities, report metrics and significant quality incidents to QA management.

  • Conduct and coordinate GCP compliance training to internal and external customers (as required).

  • Lead inspection readiness preparations (internal and external) including hosting and interacting with regulatory agencies during inspections on GCP related matters.

Qualifications & Education

  • Bachelor's degree required with 10+ years relevant GCP experience

  • Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process, conveying an appropriate sense of urgency.

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

  • Analytically strong, with great attention to detail.

  • Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement.

  • Extensive experience auditing clinical CRO's, vendors, and clinical sites.

  • Preferred related experience in GLP and/or GVP quality assurance

  • Demonstrated success in collaborating with cross functional teams

  • Experience in gene/cellular therapies a preferred

  • 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.


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Associate Director Clinical Quality Assurance & Inspection Readiness

Rubius Therapeutics, Inc.