Quality Assurance QMS, Manager

$100,000 - $125,000/Yr

Dechra Pharmaceuticals Plc - Pomona, CA

Full-time - Mid Level

Pomona, CA

1,001-5,000 employees

About the position

The Quality Assurance QMS Manager at Dechra Pharmaceuticals is responsible for maintaining and improving the Quality Management Systems at the Pomona, CA manufacturing site. This role involves promoting a quality culture, ensuring compliance with quality standards, and driving continuous improvement initiatives within the organization. The manager will oversee the QA team, manage supplier quality, conduct compliance assessments, and support regulatory inspections, all while fostering collaboration across various departments.

Responsibilities

• Promote quality culture across the site by liaising with cross-functional teams.
• Develop and manage the QA QMS team, providing coaching and mentoring on quality best practices and procedures.
• Oversee and assist with the implementation and training of new quality processes.
• Conduct compliance risk assessments and trend analysis, providing recommendations for compliant business activities.
• Oversee the Supplier Quality Management program and ensure only approved suppliers are utilized.
• Establish, compile, track, and present Quality Metrics to support Quality Management Review.
• Provide guidance for higher-level decisions required for change management and CAPA programs.
• Support and participate in internal and external regulatory inspections, ensuring compliance to procedures.
• Monitor industry inspection trends and regulations for impact on programs and operations.
• Conduct training and coaching of QA team members on documentation and record-keeping requirements.
• Supply feedback to the Head of Quality and SLT on trends and serious quality issues detected by QA staff.
• Ensure CAPAs from audits are allocated a CAPA owner and closed out appropriately.
• Perform impact assessments supporting disposition decisions for products and raw materials.
• Write, review, or approve Standard Operating Procedures and internal investigations.
• Ensure adequate QA resources are available to meet business targets.
• Proactively influence management regarding the adoption of standards to improve quality, efficiency, and compliance.

Requirements

• Bachelor's Degree in Chemistry, Biology, or a related science is preferred.
• Minimum of three (3) years of experience in a QA and/or QS role in a pharmaceutical manufacturing environment.
• Proficiency in Microsoft Office, particularly in Excel, PowerPoint, and Word.
• Experience with LIMS systems is a plus.
• Strong organizational skills and the ability to multitask.
• Demonstrated ability to work independently and as part of a team.
• Excellent communication (oral and written) and interpersonal skills.
• Proficient knowledge of cGMPs as they pertain to production facilities, manufacturing and packaging processes, and quality compliance.

Nice-to-haves

• Experience with VEEVA and Delphi systems.

Benefits

• 401(k) matching
• Competitive salary packages
• Full array of health, financial, and voluntary benefit programs