Associate Director, Quality

Catalent

2d•Onsite

About The Position

The Associate Director, Quality is accountable for the direct management and guidance in the Quality and cGMP aspects of the organization. The individual will act as the Leader of Food Safety, Quality and Regulatory activities in the manufacturing site and will be accountable for maintaining the highest standard of Dietary Supplement Manufacturing, Food Safety, Food Quality and Food Security. The Associate Director, Quality will ensure regulatory compliance with all applicable Federal, State, and Local regulations and compliance to customer and internal product specifications.

Requirements

Bachelor’s degree in Food Safety, Microbiology, Chemistry, Food Science, Engineering, or other science related field required.
Knowledge of the industry's regulatory environment, specifically with 21 CFR 111 and 117 required.
5+ years of progressive Quality experience within the dietary supplement and/or food industry, with at least 3 years in a management leadership position in a manufacturing environment required.
Excellent leadership, organizational, and communication skills. Experienced, yet energetic, and innovative with an ability to embrace the entrepreneurship of a startup operation.
Direct experience in the development and execution of Quality System, Food Safety and Sanitation programs.
Demonstrated Investigation, Root Cause Analysis, and Corrective Action capabilities.
Direct experience in the mentorship and development of direct and indirect team members.
Proficiency in Excel, Word, PowerPoint and other similar computer applications.
The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb or balance and taste or smell.

Nice To Haves

GFSI, HACCP and PCQI trained; NSF, SQF and UL certification experience preferred.

Responsibilities

Responsible for ensuring that the necessary systems are in place to support compliance with Dietary Supplement cGMP requirements for the Catalent Wellness facility, processes and people for the markets in which its products are sold.
Food Safety and Quality Team responsibility: developing, validating, verifying and maintaining Food Safety Plans and Pre-requisite programs.
Direct all functional and operational aspects of the Quality Assurance program to ensure compliance with all appropriate regulations and standards.
Supervise, provide guidance and leadership to plant Quality organization and development of the same.
Lead client, third-party, and FDA quality assurance audits along with senior management.
Develop and refine plant measurement techniques, control plan and corrective action activities. Liaise with various departments to modify standard operating procedures, and create new ones as needed.
Review and ensure compliance with plant GMP’s, HACCP, sanitation and pest control procedures and standards.
Ensure internal compliance assessments of the site are appropriately managed and that responses to resolve deficiencies are provided and communicated in a timely manner.
Execute against company established Key Performance Indicators for Quality in collaboration with Operations.
Other duties assigned.