Careers

Contract Senior Manager/Associate Director, Quality Operations

Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body to transform the treatment of cancer, infectious disease and autoimmune disease. Cue Biopharma is a high growth company and is listed on Nasdaq (CUE). The company is located in Cambridge, Massachusetts in the heart of the life sciences corridor.

Cue Biopharma is building a world-class team of highly motivated, dedicated scientists and quality operations personnel to help us advance our research and development programs. The company culture is fast-paced and committed to scientific excellence, innovation and teamwork.

Candidate Profile

As a key member of the Quality team, the Quality Senior Manager/Associate Director will report to the Head of Quality and Regulatory and be recognized as having expertise in the principles and application of quality assurance and compliance related to product disposition. The Quality Senior Manager/Associate Director is expected to coordinate GxP development and manufacturing activities in support of Drug Substance and Drug Product manufactured and tested externally at CMOs. The successful candidate will demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practice ensuring alignment with all regulatory and Cue Biopharma expectations and requirements. This is a temporary contract position that could last up to six (6) months with the potential for permanent placement. Position may require up to 10% domestic travel.

The ideal candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills as well as the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations are required. A demonstrated ability to translate strategy into action; excellent analytical skills and ability to communicate complex issues in a simple way, to orchestrate plans, resolve issues and mitigate risks are also required.

Key Responsibilities

  • Continue to improve Cue Biopharma’s overall Quality Management System (QMS) and quality Product Release/Documentation Review.
  • Responsible for clinical batch disposition, review, and quality oversight of CMOs. Review batch data, including batch records, deviations, QC/Analytical release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for review/approval of clinical lot COAs.
  • Responsible for archival of batch records and other supporting documents in electronic document control system.
  • Responsible for generating performance metrics and 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 approved vendors are used in support of GxP operations.
  • Provide 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), CAPAs and effectiveness checks.
  • Conduct and provide input into 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 compliance 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.
  • Provide Internal and External Audit / Inspection Support.
  • Participate in inspection readiness activities and provide support during regulatory site inspections (as necessary).
  • Perform vendor GxP audits as needed.
  • 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.

Requirements

  • BA/BS and minimum of 8-10 years’ experience in a Quality Assurance/Quality Systems position within a GxP environment.
  • Strong knowledge of GxP regulations, quality systems (Deviations, CAPAs, Change Control, Complaints, Recalls)
  • Ability to support a risk-based approach to QMS with knowledge of and experience with Quality Risk Management principles.
  • Experience with contract manufacturing and contract testing organizations.
  • Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures.
  • Should be highly motivated, flexible, and have excellent organizational and communication skills.
  • Must be able to work both independently and as part of a multi-disciplinary team.
  • Ability to travel to meet program needs (est. up to 10%).

To apply, please email your resume to careers@cuebio.com. In the subject line include your name and the posted job title.

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