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Associate Director/Director Quality Assurance

OcyonBio PR INC
00603, PR
  • Posted: over a month ago
  • Full-Time
Job Description


The Company

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

The Role: The Director, of Quality Assurance, is responsible for executing the Quality System at one of our client’s new GMP facilities in Puerto Rico and will work closely with the development team to establish and support standards for GXP compliance. The manufacturing facility will include the entire product life cycle, including Cell banking, Drug Substance, Drug Product, and Pack/Label activities in an aseptic/sterile environment.

Duties and responsibilities:

• Play a key role in the development of the Master Validation Plan and individual validation plans. Assist in the development of the overall validation strategy for one of our client’s new GMP facilities.

• Provide GXP quality assurance (QA) support activities consistent with FDA, EU, and ROW requirements to support cell therapy and biologics programs.

• Establish QA strategy and operational objectives.

• Represent the QA function in CMC meetings.

• Manage both the external vendor qualification program and internal audits. Conduct GMP vendor qualification audits and processes relating to clinical drug development.

• Responsible for managing deviations, investigations, change control, and OOS processes.

• Responsible for approving master batch records and specification documents.

• Responsible for review of QC analytical method validation/qualification protocols, reports, test methods, and GMP test results to assess the suitability of product disposition.

• Coordinate and conduct batch record review and lot disposition (Cell Banks, API/DS, DP & Labeling/packaging). • Be a resource as our client voice of Quality for GMP requirements.

• Participate in inspection readiness preparation, and corrective action responses.

• Ensure/establish QP declaration across programs and supply chain. Ensure chain of custody for shipment of product. • Manage day-to-day emerging QA issues.


• BS and 10+ years of QA experience in the Life Science industry. MS preferred.

• Minimum of 5 years of QA auditing experience with outsourced cell therapy and/or biologics manufacturing vendors.

• Experience with cell therapy and/or biologic programs required.

• Proficient knowledge and direct experience with global GMP requirements.

• Must have excellent interpersonal, organizational, and communication skills as well as the ability to work effectively and independently as part of a multidisciplinary team.

• Must have close attention to detail and provide hands-on support for operational activities.

What we offer:

• Competitive salary (DOE)

• 401(k) employer match, health, dental, vision benefits.

• Professional training and development opportunities.

Working conditions:
  • Office with a mix of natural and LED lighting with a low background noise level. Required computer and conferencing hardware are provided. 20-40% seated at a desk with ergonomic and sit/stand desks.
  • Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab gowns, glasses, and gloves.
  • Local, national, and international travel may occasionally be required (up to 25%

If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

To learn more about us, please visit our website:

OcyonBio PR INC


00603, PR
00603 USA



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