Quality Assurance Lead

3 weeks ago

Miami, United States GL Staffing Services Full time

For a Pharmaceutical manufacturing company we're looking the following:

  • Position: Quality and Regulatory Lead
  • Direct Hire with full benefits
  • 100% on-site position
  • Salary range offered: $110 - 140/K
  • Location: Miami Lakes, Fl.



Please make an application promptly if you are a good match for this role due to high levels of interest.

Position Description:

Manages the functions for the Quality Systems, Regulatory Compliance and Documentation Systems.

Position is responsible for the overall cGMP compliance at the site.

Responsible for verifying that all departments sustain compliance with applicable regulatory requirements and remains in permanent inspection readiness state.

Manages function of the Quality Unit responsible for documentation administration, change management program, deviation and customer complaint systems, packaging component life-cycle process (artwork/package engineering/specification development) supporting technical and quality operations.

Quality reviews/oversight/approval of process/packaging/computer system validation activities.

Regulatory responsibilities include interaction with all regulatory and third-party auditors during site visits.

Responsible for the response to audit observations and commitments to follow-up.

Manages the Product Quality Review (PQR) process, including review, follow-up action and notification to management.

Responsibilities:

Manages the overall strategy for the implementation and maintenance of Quality Systems and documents. This includes:

  • Assessment and remediation of existing systems against current practice and agency regulations and maintains compliance through improvement projects.
  • Manages permanent inspection readiness to assure compliance of systems and processes and external suppliers/contractors to regulatory requirements.
  • Coordinates activities concerning field alerts and recall program.
  • Coordinates and manages quality and authors response to inspection observations.
  • Manages the development, review and approval of Quality Agreements with suppliers.
  • Controls and maintains regulatory documentation such as NDA and DMF.
  • Manages the PQR process from data collection through reporting of results. Ensures appropriate actions are taken in response to PQR variances.
  • Manages Change Management, Deviation/Investigation/CAPA and Customer Complaint systems to ensure compliance with site procedures and agency requirements.
  • Provides direction and prioritization for projects in documentation, change management, process/raw materials, packaging and material/supplier qualifications.
  • Ensures that commitments and corrective/preventive actions are tracked to completion and are effective.
  • Reports metric/trending to management.
  • Provides knowledge of NDA documents.
  • Ensures documentation practices are compliant with regulatory requirements.
  • Ensures raw materials and packaging components material/supplier qualifications are performed in accordance with product NDA requirements and with proper protocol execution and change control.
  • Maintains Quality oversight, review and approval of all packaging/facility equipment, computer validation activities at the site.
  • Maintains adequate staffing assessment and requirements to accomplish department initiatives and goals.

Supervisory Responsibilities

The Quality Assurance Lead manages the Quality Assurance Department

Experience & Qualifications

  • Bachelor’s degree in biology, Chemistry or Pharmacy preferred.
  • A minimum of 5 years of experience in the pharmaceutical industry with manufacturing and/or quality assurance experience in the pharmaceutical manufacturing,
  • An equivalent mix of education and Quality Assurance experience will be considered.
  • No less than 3 years of supervisory experience.
  • Excellent oral and written communication skills.
  • Excellent written and spoken English.
  • Ability to read, analyze and interpret complex documents.
  • Ability to respond effectively to the most sensitive inquiries or complaints.
  • Ability to write technical documentation.
  • Ability to make effective and persuasive presentations.
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
  • Ability to deal with non-verbal symbolism (such as formulas, scientific equations, graphs, etc.) Identifies and understands issues, problems, and opportunities; compares data from various sources to draw conclusions.
  • Ability to train employees and delegate work assignments/projects effectively.

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