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Sr Dir of Quality

Biosimilr Sciences PR LLC
00603, PR
  • Posted: over a month ago
  • Full-Time
Job Description

Job Description: SENIOR DIRECTOR QUALITY CONTROL

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 Senior Director of Quality Control Laboratories is responsible for executing the quality control strategy and running the quality control laboratories for Ocyonbio. The incumbent will work closely with the analytical development team to establish and support standards for GxP compliance. He or she is responsible for cGMP compliance ensuring all regulations, internal procedures, and other regulatory requirements are adhered to. Ensure all preclinical, clinical, or commercial products manufactured, processed, packed, or held at the site meet requirements for product identity, strength, quality, and purity, including products for regulatory submission. In addition, the incumbent will manage, direct, and mentor the laboratory staff.

Duties and responsibilities:

Responsibilities


  • Promote a positive quality culture and oversee on-the-floor quality presence in the respective business area (e.g. manufacturing and Quality Control Labs).
  • Provide quality direction for complex business and operational issues or technical challenges. Remove barriers as they arise.
  • Manage the laboratories as a well-planned operational area with appropriate work- load forecasting, planning, capacity analysis, and others.
  • Work closely with supply chain and manufacturing to assure the factory has the right cadence.
  • Drive high performance with key metrics such as performance against schedule and right first time as leading management tools.
  • Oversee data integrity for paper-based and electronic systems, including quality review of audit trail reviews. Ensure compliance with applicable standards and regulatory guidelines (e.g. 21 CFR Part 11 related to computer systems).
  • Evaluate and approve change controls, risk assessments, excursions, and deviation investigations. Recommend CAPAs and ensure CAPAs implemented are effective. Ensure that quality system-related changes/deviations are evaluated consistently.
  • Prepare site for regulatory inspections. Host regulatory and business partner inspections/audits and coordinate inspection/audit responses and commitments.
  • Review/approve standard operating procedures, batch records, specifications, validation protocols and reports, instrument acquisitions/decommission, and work orders, as applicable. Ensure processes are harmonized across multiple business areas.
  • Serve as a key quality resource in leadership teams and/or other forums as required and provide compliance guidance to manufacturing and other supporting business units.
  • Collaborate with cross-functional departments during planning and process/continuous improvement projects and initiatives to ensure timely completion (e.g. quality plans objectives and milestones).
  • Identify and lead process improvement projects impacting multiple business areas.
  • Provide quality control oversight for technology transfers to the OcyonBio facility.
  • Oversee and monitor Quality metrics. Ensure data compiled is communicated in relevant forums and escalate compliance issues to senior management.
  • Mentor, coach, and manage staff performance and development.
  • Plan, administer, and monitor the department budget.

Qualifications - Skills & Requirements

  • Experience at a sterile manufacturing site is required
  • Aseptic processes and associated experience
  • Technical and leadership responsibility Special knowledge or skills needed and/or licenses or certificates required
  • Expert knowledge of GMPs in the US and global pharmaceutical industry
  • Excellent hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
  • Proven track record of successful interactions with the FDA and other health authorities
  • Experience with the execution, coordination, and tracking of Quality Management Systems (QMS) procedures and related activities
  • Proven people management experience
  • Ability to influence without direct authority

Education & Experience

  • Bachelor’s degree in a Science or related field
  • Up to 10 years of experience at a senior level in the pharmaceutical or biotechnology industry in quality or compliance positions

What we offer:

• Competitive salary (DOE.)

• Health, dental, and vision benefits.

• Professional training and development opportunities.

• Opportunities to participate in the company stock options program

Working conditions:

Physical Requirements


OFFICE POSITION - While performing the duties of this job the employee is required to:

  • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
  • Specific vision abilities required by this job include close vision requirements due to computer work
  • Light to moderate lifting is required
  • Moderate noise (i.e. business office with computers, phones, and printers, light traffic).
  • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.


We Are An Equal Opportunity Employer

Ocyonbio provides 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 veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.

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.

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.

To learn more about us, please visit our website: https://ocyonbio.com

Biosimilr Sciences PR LLC

Address

00603, PR
00603 USA

Industry

Manufacturing

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