Quality Systems Senior Specialist

About Us:Perceive Biotherapeutics () is an exciting early-stage company, funded by Deerfield Management, with a team focused on improving human health by developing breakthrough neuroprotective therapeutics. We are using novel approaches to treat highly prevalent, blinding diseases that currently have no good therapeutic alternatives. Our unique approach is leading to first-in-class and best-in-class small molecule and gene therapy solutions that will significantly impact patients’ lives.

Position Summary:The Quality Systems Specialist will play a key role in ensuring the effectiveness and compliance of our Quality Management System (QMS). This position is ideal for a self-driven professional who thrives in a fast-paced, start-up environment and is passionate about contributing to the development of life-saving products. The role requires collaboration across multiple departments to maintain and improve quality systems in alignment with regulatory requirements (FDA, EMA, ICH, etc.)

and industry standards.

Key Responsibilities:

• Help to develop and optimize the company’s Quality Management System (QMS) to ensure compliance with regulatory requirements, internal procedures, and industry standards.
• Support the implementation and oversight of key quality systems, such as Document Control, Supplier Management, Deviations and Complaints.
• Collaborate with cross-functional teams to ensure alignment of quality systems with the company’s overall quality objectives and product development timelines.
• Lead or support investigations into quality-related issues, perform root cause analysis, and ensure timely resolution.
• Develop and deliver training programs on QMS procedures, quality standards, and regulatory requirements for internal staff.
• Review and approve quality documentation, such as SOPs, batch records, and technical reports.
• Assist in the preparation of regulatory submissions, including detailed review of data and reports to ensure alignment.

Qualifications:

• Bachelor’s degree in Life Sciences, or a related field.
• Minimum of 5 years of experience in Quality Systems, Quality Assurance, or a related role within the pharmaceutical or biotechnology industry (medical device background considered).
• Strong understanding of regulatory requirements (FDA, EMA, ICH, GMP) and quality management principles.
• Experience with Document Control, Complaint and Supplier Management Systems in a virtual company.
• Ability to conduct audits and investigations into quality issues.
• Excellent organizational skills with the ability to manage multiple tasks and deadlines in a fast-paced environment.
• Strong communication skills, both written and verbal, with the ability to work collaboratively in cross-functional teams.
• Proficiency in MS Office and working in Box.
• Detail-oriented with a proactive problem-solving approach.
• A passion for quality, compliance, and continuous improvement in a start-up environment.

Preferred Qualifications:

• Experience in early-stage drug development and/or manufacturing.
• Knowledge of quality systems software platforms.
• Experience with Benchling

Location

SF Bay Area or San Diego, CA

This is a full-time contract position that is hybrid (primarily remote) with a potential to convert to full-time.

Targeted annual pay band is $,000 with some flexibility commensurate with experience.

If you are a motivated and detail-oriented individual who thrives in a start-up environment and is passionate about ensuring the highest standards of quality, we would love to hear from you. Apply today to join our mission to transform the future of healthcare!

Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

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