Launch a high-impact, 2-year contract as an Associate Director Quality Capital Programs with a top-tier global pharmaceutical leader. This role is 100% remote, strategically supporting a major new sterile campus project in North Carolina. You will provide critical quality assurance oversight from early design through commissioning and qualification, ensuring robust contamination control and GMP compliance.
location: Telecommute
job type: Contract
salary: $60.00 - 72.61 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Lead quality oversight and GMP Design Review Risk Assessments for sterile manufacturing capital programs.
- Act as the primary Quality representative on cross-functional engineering and project teams to uphold contamination control principles.
- Evaluate critical design elements and review qualification documents using risk-based qualification methodologies.
- Standardize GMP design review templates and integrate regulatory compliance feedback into the corporate quality system.
- Collaborate with Centers of Excellence to continuously improve commissioning, qualification, and validation procedures.
qualifications:
- Bachelor's or Master's degree in Microbiology, Science, or an Engineering-related discipline.
- Minimum 10 years of experience in aseptic manufacturing and QC Microbiology.
- Comprehensive understanding of biological/pharmaceutical technologies and quality assurance mindsets.
- Strong knowledge of pharmaceutical regulatory requirements (FDA, EMEA, EU GMPs, ICH Q9, and PIC/S) supporting contamination control and GMP design.
- Demonstrated experience with risk-based qualification (such as ISPE Baseline Guide Volume 5).
skills: Project Management, MS-Project, Microbiology, QC Review, Good Manufacturing Practices (GMP), Quality Control (QC)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
