Job description

Associate Director – Clinical Quality

The Company

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

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

Job Summary

As a key member of the Quality team, reporting to the Head of Quality and Regulatory, the Associate Director is recognized as an internal expert in the principles and application of quality assurance and compliance related to product disposition. The Associate Director provides GxP guidance and oversight of clinical development, clinical operations, and CMC manufacturing activities in support of Cue Biopharma’s products. The successful candidate demonstrates a high level of involvement in continuous improvement of quality assurance philosophy and practices ensuring alignment with all regulatory and CUE Biopharma expectations and requirements. Position may require up to 10-15% domestic travel.

Candidate Profile

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, ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Key Responsibilities

• Continue to improve Cue Biopharma’s overall Quality Management System (QMS).
• Responsible for quality oversight of clinical development and clinical operations.
• Responsible for review/approval of clinical lot COAs.
• Ability to work electronic document control system.
• Responsible for generating performance metrics and trends related to Clinical Quality.
• Liaise with key stakeholders to ensure only approved 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), 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 compliant investigations and recalls as necessary.
• 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.
• Review and approval of product stability and reference standard data.
• Review drug product temperature excursions for Clinical Trial Material.
• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
• Function 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.
• 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.
• Provide oversight of GLP/Laboratory as needed.
• Assist as needed with review and/or audits of laboratory documents such as protocols, study reports, and regulatory submission documents.

Requirements

• BA/BS and minimum 8-10 years' experience in a Quality Assurance/Quality Systems position within a GxP environment.
• Strong knowledge of Clinical Quality, 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 CRO’s and Clinical Labs (Central and Testing).
• 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 (may require up to 10-15% domestic travel).

Equal Employment Opportunity Policy

Cue Biopharma champions equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected military or veteran status, marital or registered civil partnership status, pregnancy or parental status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Cue Biopharma will endeavor to ensure that any individual with disabilities who is qualified for the position in question is provided reasonable accommodation to participate in the job application process.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• Monday to Friday

Work Location: Remote

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