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Director of Quality Operations

TissueTech Inc
Miami, FL
  • Posted: over a month ago
  • Full-Time
Job Description

Position Summary

Responsible for quality operations at the Company’s manufacturing sites including management of site-based quality teams performing Raw Material incoming inspection and release, lot release, site quality management systems, site quality engineering, and site sterility assurance. Serve as the subject matter expert on GTP/GMP requirements, ensuring that systems and procedures are in accordance with applicable laws and regulations.

Essential Duties & Responsibilities

Supervise quality staff that are supporting manufacturing facility activities and provide direction for daily activities to include problem solving and mentoring

Oversee and manage the quality teams responsible for supporting all aspects of site activities including, but not limited to: manufacturing, packaging, labeling, and distribution

Responsible for prioritizing quality team workday schedules and deliverables to support manufacturing and supply chain partners. Track team performance metrics and collaborate with Operations partners at the site to ensure alignment of priorities

Serve as the subject matter expert for the site’s quality system and site quality metrics. Understand site standard operating procedures and work instructions as well as the core quality management systems and how they interrelate. Understand what GxP activities and records are the outputs of these quality systems

Optimize the site-based standard operating procedures, work instructions and forms as part of continuous improvement of the site quality management system

Review and approve standard operating procedures, work instructions as well as protocols & reports for the manufacturing sites (including, but not limited to process validation & equipment qualification)

Apply the key quality requirements of GTP/GMP, ISO & AATB as part of product and process improvements using the appropriate quality system elements (Change Control, Nonconformance Management, CAPA, Audit, etc)

Support internal partners in Operations (Technical Operations, Supply Chain, Production), and Research & Development to transfer product and process improvements from R&D into the manufacturing sites

Oversee the tracking and trending of site quality performance data against quality systems metrics.

Monitor and report on all quality issues to the Quality Management Representative; develop and present site metrics with the site Operations teams to identify opportunities for improvement.

Perform the functions necessary for the effective management of the site’s Quality department, including provision for the selection and development of employees, budget administration, cost control, employee safety, employee counseling and motivation.

Work with other department supervision/management to resolve quality issues.

Conduct a continuing education program as it relates to pertinent requirements in a regulated facility.


Position Expertise/Qualifications

Degree/Diploma

Program of Study Preferred/Required

Obtained


Bachelors Life Sciences or related field of study Required

Master’s Life Sciences, QA/RA, MBA or related field of study Preferred


Certification & Licensures Required/Preferred

American Association of Tissue Banks (AATB) Certified Tissue Banking Specialist (CTBS)

Preferred

American Society for Quality (ASQ) Certified Quality Engineer (CQE)

Preferred

Certified Quality Auditor (CQA)

Preferred




Minimum

Years of Type of Experience

Experience

Required/Preferred

15+ years FDA regulated industry Required

5 years

QA and Management

Required

5 years

2 years

Electronic quality management system

ERP systems

Required

Preferred





Skills & Abilities

Ability to make informed decisions, think critically and strategically, solve problems and respond proactively; must have excellent communication skills (both written and oral); strong time-management skills required.


Fluent (oral/written) English.

Computer Proficiency – Word, Excel and Access, Electronic Quality Management Systems.



ADA Statement

Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the essential functions of the position with a reasonable accommodation.



Employee Statement of Understanding

I have read and understood the position description for my position. I am able to perform all of the essential functions of this position with or without a reasonable accommodation. I understand that I may be assigned additional functions and backup duties that are not specified within this position description.

I agree to comply with the corporate compliance policy and all laws, rules, regulations and standards of conduct relating to my position. As an employee, I understand my duty to report any suspected violations of the law or the standards of conduct to my immediate supervisor.

As an employee, I will strive to uphold the mission and vision of the organization. All employees are required to adhere to the values in all their interactions with customers and fellow employees.

TissueTech Inc

Address

Miami, FL
33122 USA

Industry

Manufacturing

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