Quality Assurance Director

Quality Assurance Director 2.8 2.8 out of 5 stars 69 Princeton Hightstown Road, East Windsor, NJ 08520 $150,000 - $200,000 a year - Full-time ForDoz Pharma Corp. 5 reviews $150,000 - $200,000 a year - Full-time Job Brief We are looking for a Quality Assurance Director who manages the daily work activities of the Quality Assurance group to ensure products manufactured by ForDoz Pharma comply with global/local regulations, guidelines, and operating procedures. Job Responsibilities

• Ensures products manufactured by ForDoz Pharma are in compliance with global/local regulations, guidelines and operating procedures
• Provide QA Oversight (training of current QA staff, review of their work, review of site quality compliance, innovation of current processes/equipment)
• Collaborate with cross functional groups: QC, Operations, Product Development, Facilities, and Regulatory Affairs and provide interpretation/clarification on regulations, guidelines, policies, and procedures.
• Participate in establishing the company's quality management and documentation systems, and ensure that all company activities comply with cGMP.
• Evaluate current policies and procedures and update for continual process improvement.
• Assist in establishing site quality metrics and perform site quality metric trend analysis
• Develop commercial processes such as: complaint system, annual product review, and recall program.
• Assist in facilitating regulatory inspections.
• Perform external vendor and internal departmental audits to assess compliance with applicable regulations/guidelines and internal SOPs/expectations. Evaluate audit findings, prepare, and distribute reports.
• Provide back up to Quality Director Requirements Bachelors or Master degree in chemistry, biology, pharmacy, engineering or other scientific discipline or related field 7+ years relevant experience in commercial pharmaceutical manufacturing (at least 4 of the 7 years in QA) 3+ years managerial experience Considerable knowledge of quality assurance processes and procedures.

Extensive knowledge of cGMPs, ICH, and other pharmaceutical regulations Experience in Quality Systems including auditing and change control process is preferred Experience in laboratory (Chemistry or Microbiology), aseptic processing, and/or manufacturing is preferred

• Familiar with Operational Excellence (Six Sigma), Quality by Design, Quality Risk Management, Root Cause Analysis tools. ASQ certifications is a plus.
• Demonstrated strong management and leadership skills in implementing program/organization strategies
• Be able to work efficiently and handle multiple task simultaneously
• Has excellent communication skills (both oral and written).
• Work hard and be a team player
• Please note this position is not eligible for employment visa sponsorship now or in the future ForDoz Pharma Corp.

is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics

Job Type:

Full-time Pay:

$150,000.00 - $200,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance Application Question(s): Do you have experience with sterile injectables? Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?

Education:

Bachelor's (Required)

Experience:

pharmaceutical manufacturing: 7 years (Preferred) Ability to

Commute:

East Windsor, NJ 08520 (Required)

Work Location:

In person