Principal Product Quality Leader

Product Quality Team Leader

Payrate: $64.00 - $65.00/hr summary:
Our corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader. You will provide technical expertise and leadership within a Product Quality Team, engaging with various departments on a variety of activities such as product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions, and inspections.

You will support one or more of our late-stage or commercial synthetic products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. Your contributions will significantly improve initiatives intended to ensure the overall product health.

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.

Qualifications

• Pharma or biotech experience.
• Understanding of operations.
• Tactical in nature - able to receive tasks and work independently once trained (will be training period).
• Good communication skills.
• Attention to detail.

Pay Transparency:
The typical base pay for this role across the U.S. is: $64.00 - $65.00 /hour . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience.

Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus.

Sick leave and mobile phone reimbursement provided based on state or local law.