21 July 2020
Director, Quality and Compliance – Pharmaceutical

Director, Quality and Compliance – Pharmaceuticals
Sunrise, Florida
 
Job Summary:
This is a Senior role within the organization reporting to global head of Quality Manufacturing.
 
The Director, Quality & Compliance has oversight over all GxP activities and functions including
  1. Quality Manufacturing & Release,
  2. Quality System, Quality Control,
  3. Microbiology, Compliance, and
  4. Risk Management. 
This role acts as a Business Partner, ultimately responsible for Quality and Compliance processes in the organization – in full compliance with GxP.  Quality cannot be compromised.
 
The Director, Quality & Compliance is the appointed Management Representative for the company with the authorities and responsibility for ensuring that quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820 and Ensures organization is 21 CFR Part 11 compliant
 
Job Responsibilities:
  • Quality Systems, ensuring compliance with GMPs, Global Policies and SOPs.
  • Product Development, Technical Operations, and Regulatory Affairs
  • Perform site wide GMP documentation gap analysis against Global Quality Policies & SOPs, and revise documents as needed.
  • Ensures organization is 21 CFR Part 11 compliant
  • Represent Company before Regulatory Agencies and Industry Groups
  • LEAN deployment and a continuous improvement mindset is a must
  • Gap Analysis in order to maintain GMPs in compliance with GxP, regulatory standards
  • Assist the VP, Global Quality Manufacturing sites in following up on the assigned tasks given; performs the essential duties of a Quality management
  • Responsible for attracting, developing and retaining best in class personnel
  • Responsible for creating a high-quality work environment when the team feels engaged and accountable
  • Development and maintenance of effective CAPAs
Requirements:
  • Master’s Degree in Chemistry, Pharmacy, or related scientific field 
  • Manufacturing facility experience, and knowledge of regulations and practices pertaining to pharmaceutical/biological products
  • Experiential knowledge and application of Food and Drug Administration (FDA), Health Canada and other international regulations
  • CAPA experience
Experience:
  • 10 years of experience in Pharmaceutical Quality Operations
  • 5 years of experience in a management/leadership position 
/- 10% travel
 
The company offers excellent benefits, yearly bonus and LTIP (Long-Term Incentive Plan).
 
  Please submit your resume in a word document format.  Make sure you have the month/year for all employment listed. You will be contacted by phone/email ASAP! 
 
Please consider following us on LinkedIn:
https://www.linkedin.com/company/ttg-talent-solutions-inc/



 
 
 
 
 
 
 
At ttg, “We believe in making a difference One Person at a Time,” ttg OPT.
  • Quality Control
  • Microbiology
  • Pharmaceutical