Aptask Global Workforce (AGW) is seeking a Principal Product Quality Leader for a Remote position with a Global Biotechnology Company. This is a contract opportunity. Our client's corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader to provide technical expertise and leadership within a Product Quality Team. You will support one or more of our client's late-stage or commercial synthetic products and will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems, and product data management.
Responsibilities: - Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
- Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
- Conduct science and risk-based evaluation of complex process and product quality data
- Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
- Extract and analyze data from various sources and Quality systems
- Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Requirements: - Doctorate degree and 3 years of experience OR Master's degree and 5 years of experience OR Bachelor's degree and 7 years of experience OR Associate's degree and 12 years of experience OR High school diploma / GED and 14 years of experience
- Experience in the Pharmaceutical or Biotechnology industry
- Good communication skills
- Strong attention to detail
- Understanding of operations
- Tactical in nature; able to receive tasks and work independently once trained
Desired skills: - Prior experience with the client is highly preferred
Pay range: up to $69.08 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
Never miss an opportunity! Create an alert based on the job you applied for.