Director, Quality Compliance

Location: Buena, NJ

Job Summary:

The compliance director is responsible for policy and procedure remediation and development, vendor auditing and management in order to confirm conformance to all Teligent Quality expectations, operational adherence to internal and external statutory and regulatory requirements, audit leadership, and management of all field alert reports (FARs) and recalls. This position participates in ensuring compliance in all areas of the organization including product development, compounding, and manufacturing and interacts with all site and corporate management and personnel.

Essential Responsibilities:

  •  Serves as the company’s current Good Manufacturing Practices (cGMP) expert by keeping abreast of all current regulatory and statutory expectations and keeping the organization in a state of permanent inspection readiness.
  • Serves as the primary audit leader and ensures compliance to all domestic and foreign regulatory and statutory requirements.  This includes the code of federal regulations (CFR), the EudraLex, and all guidance documents that will be used to assess our compliance to industry standards.
  • Ensures corporate policies are accurate, current and in compliance with all applicable regulations. Reviews and updates policies as the industry expectations change.
  • Interprets and disseminates information on all compliance and regulatory matters.
  • Vendor management and compliance.
  • Collaborates with operational counterparts in order to train and mentor all company personnel in order to drive proactive improvements into the organization.
  • Assesses all aspects of our Quality Management System through direct shop floor observations and audits. Identifies and remediates all observations through robust Corrective and Preventative Actions (CAPAs) and then determines the efficacy of these actions through periodic effectiveness checks.
  • Interfaces with training to enhance our training program, which will be structured to address issues that illustrate positive trending.
  • Assists with regulatory and compliance training
  • All other duties assigned by the department head.

Qualifications:

  • Familiarity with the salient portions of the Code of Federal Regulations and the EudraLex
  • Experience with regulatory filings
  • Quality operations and auditing background
  • Communication Proficiency
  • People Management
  • Time Management
  • Demonstrated Technical Capabilities
  • Thoroughness
  • Ethical Conduct
  • Bachelor’s degree in biology, chemistry, physics, engineering or a related field or equivalent experience.
  • A minimum of five years of compliance and/or regulatory experience.

Physical Demands/Factors:

  • While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs

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