Sr. MGR Quality Operations

$131,200 - $218,600/Yr

Pfizer - Bothell, WA

Full-time - Senior

Bothell, WA

Chemical Manufacturing

About the position

As a Senior Manager in Quality Operations at Pfizer, you will play a crucial role in ensuring the quality and compliance of clinical and commercial drug batches. Your responsibilities will include evaluating product and process documents, managing quality assurance activities, and leading a team to achieve quality excellence. You will set objectives for multiple projects, oversee compliance with regulatory standards, and foster a culture of continuous improvement within the organization.

Responsibilities

• Evaluate and review clinical and commercial batches of drugs to ensure compliance with specifications.
• Set objectives for multiple projects within the division to drive quality excellence.
• Ensure compliance of site Quality and Regulatory Systems with regulatory filings and submissions.
• Work with Business Excellence and Operations to manage vendor relationships and conduct audits.
• Provide Quality Assurance Compliance guidance to the QC team.
• Manage performance of direct and indirect reports through goal setting and performance evaluation.
• Prepare and deliver training on Good Manufacturing Practices (cGMP) and Quality Systems.
• Conduct quality reviews and report results to relevant stakeholders.
• Develop and implement global quality and compliance expectations across the product lifecycle.
• Support audits and inspections as needed.
• Act as a Subject Matter Expert on training management and Pfizer's Global Learning Management System.
• Encourage lean operations by reviewing and improving existing work practices.
• Establish standards and procedures to ensure compliance with regulatory requirements.

Requirements

• Bachelor's Degree
• 7+ years of experience in quality operations or related fields.
• Strong people management experience.
• Experience in GMP-regulated industries and process validation.
• Previous involvement in the drug development process.
• Successful interaction with global regulatory and auditing groups.
• Thorough knowledge of pharmaceutical API products and Current Good Manufacturing Practices (cGMP).
• Excellent verbal and written communication skills.

Nice-to-haves

• Master's degree
• Knowledge of training design and tools, and experience in applying training methodology.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage