Director of Quality Systems Details

Director of Quality Systems

Pharmatech Associates - Miami, FL

Employment Type : Full-Time

We are looking for a Director of Quality Systems to join our consulting team and provide market leadership for the Life Science industry. This is a contract position for a client located in the Miami, FL area.

Responsibilities

• Serve as the subject matter expert for the overall quality system and its subsystems that work together as part of the GTP/GMP and Quality Management System.
• Apply the key quality requirements of GTP, FDA & AATB requirements to manufactured products
• Accountable for adequate oversight and management of the quality related activities.
• Accountable for adequate and effective monitoring of the Quality Auditing program.
• Review for adequacy, evaluate from a quality perspective and approve equipment qualifications (IQ/OQ) and validation protocols & reports.
• Oversee the preparation, review and approval of corrective action reports, nonconformance reports, change requests, and customer complaints relating to tissue, device or cell-based products.
• Oversee the tracking and trending of quality performance data to monitor and report on all quality issues to Management w/ Executive Responsibility; develop/present metrics in a useable format (i.e. Annual Quality Review) to identify quality performance/trends to Top Management and others, if requested (i.e. investors).
• Oversee, manage and maintain quality initiatives such as ISO re-certification, AATB re-certification, industry best-practices initiatives and continuous improvement activities.
• Perform the functions necessary for the effective management of the 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.
• Participate on the Medical Advisory Committee as the Quality Representative
• Serve as Management Representative with the authority over and responsibility for ensuring the Quality System requirements are effectively established and maintained.
• Serve as the subject matter expert on GTP regulatory requirements for the Technical Division.
• Provide regulatory review for critical GTP documentation, including but not limited to: Donor Eligibility Determination procedure, TTI Exclusionary Criteria, Donor Risk Assessment Interview and Core Elements of Informed Consent.

Qualifications

• Bachelors degree in life sciences plus 10 years of relevant life science industry experience and at least 5 years of management experience including hiring, mentoring and leading teams
• Candidate should have 7+ years’ experience in biologic drug QA leadership position
• Candidate should be fluent in Good Tissue Practices (GTP) and Biologics GMP
• American Association of Tissue Banks (AATB) Certified Tissue Banking Specialist (CTBS) is preferred
• American Society for Quality (ASQ) Certified Quality Auditor (CQA) is preferred

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.