Sr. Auditor

Your Role:

The Quality Auditor is responsible for ensuring compliance with regulatory requirements and internal quality standards within a pharmaceutical environment. This role encompasses conducting audits, managing quality systems, and overseeing supplier quality management to ensure that all operations adhere to cGMP, FDA, and other regulatory standards.

Major Responsibilities:

• Conduct Audits:

Scheduling, preparing, conducting, and reporting internal and external audits of manufacturing processes, quality systems, and suppliers.

Evaluate compliance with cGMP, FDA, EU regulations, and internal quality standards.

Prepare detailed audit reports summarizing findings, non-conformances, and recommendations for improvement.

Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs) in response to audit findings and supplier issues.

Monitor the effectiveness of CAPAs and ensure timely resolution of identified problems.

• Quality System Management:

Participate in mock-inspections, as appropriate.

Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.

Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.

• Supplier Management:

Conduct assessments and audits of suppliers to evaluate their compliance with quality standards and regulatory requirements.

Collaborate with suppliers to develop and implement corrective actions for identified issues.

Maintain supplier quality metrics and monitor supplier performance to ensure adherence to quality agreements.

Who You Are

Minimum Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field or equivalent experience.
• Minimum of 7 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.
• Domestic travel to supplier sites and other company locations is required. Up to 25%
• Auditing experience within regulated biotech/pharma industry or equivalent.

Preferred Qualifications:

• Certified Quality Auditor (CQA) or equivalent certification.
• Strong knowledge of cGMP, FDA, and EU regulations related to pharmaceuticals.
• Ability to interpret and apply regulations, regulatory guidance, and codes and identify and recommend compliance changes as appropriate.
• Experience with quality system management and supplier quality assurance processes.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a team environment.
• Strong attention to detail and organizational skills.
• Performance of this work requires limited supervision.

Pay Range for this position: $101,400-152,000

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. ​