Associate Director, Quality Assurance

Scorpion Therapeutics; Pennsylvania; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) retirement

Paid holidays/vacation

Compassionate and sick days

Job summary

Scorpion Therapeutics in Pennsylvania is seeking a Senior GLP QA Auditor to lead global QA audits and ensure compliance with FDA GLP/OECD guidance across sites.

You will manage audits, mentor QA staff, develop training, and serve as the key inspection liaison, delivering regulatory perspective and CAPA resolution.

This role requires 8+ years of regulated pharma audit experience and hands-on experience with FDA/OECD GLP, with familiarity of tools like Veeva/LIMS/Pristima being preferred.

Qualifications

• 8+ years of audit experience in regulated pharma/biopharma/biologics.
• Extensive FDA and OECD GLP knowledge; experience leading audits.
• Leadership; cross-functional teamwork; electronic quality systems experience.
• Strong attention to detail; Microsoft Office; excellent written/verbal communication; manage competing priorities.

Responsibilities

• Facilitate communication and alignment with key stakeholders.
• Execute and close global GLP QA audit activities and ensure FDA/OECD guidance compliance.
• Conduct GLP and regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits using QA risk-based processes.
• Lead liaison for QA activities supporting regulated work across sites.
• Independently function as a lead auditor; provide regulatory perspective/quality advice.
• Plan, prioritize, schedule, monitor, document audits; track findings and CAPA.
• Maintain regulatory knowledge; interpret and distribute guidance.
• Develop and deliver compliance training; mentor QA staff; participate in committees.
• Manage multiple projects; lead escalation and CAPA/root-cause assessment.
• Serve as inspection management point; represent GLP QA on cross-functional teams.

Skills

Audit Management

Collaborative Leadership

Project Leadership

Quality Assurance Systems

Quality Oversight

Regulatory Compliance

Education

Bachelor's degree in Science/Engineering/IT

Tools

Pristima

Veeva

LIMS

Empower

Electronic lab notebooks

Job description

Primary Responsibilities:

• Facilitate communication and alignment with key stakeholders.
• Execute and close global GLP QA audit activities (domestic/international sites and contract facilities) and ensure compliance with FDA GLP/OECD guidance, company policies, procedures, and QA SOPs.
• Conduct GLP and regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits using QA risk-based processes.
• Lead liaison for QA activities supporting regulated work across sites.
• Independently function as a lead auditor; provide regulatory perspective/quality advice.
• Plan, prioritize, schedule, monitor, document/track audits/inspections, ensure timely resolution of findings, and report findings to appropriate personnel.
• Maintain expertise in applicable worldwide regulations; interpret and distribute regulatory guidance as needed.
• Develop and deliver compliance training; mentor less experienced QA staff; participate in committees.
• Manage multiple/moderately complex projects; lead escalation and support CAPA/root-cause assessment.
• Serve as key point person for inspection management; represent GLP QA/QA on cross-functional teams.

Education:

• Bachelor’s degree in an appropriate Science, IT, or Engineering discipline.

Required:

• 8+ years of audit experience in regulated pharma/biopharma/biologics.
• Extensive FDA and OECD GLP knowledge; experience leading audits.
• Leadership; cross-functional teamwork; electronic quality systems experience.
• Strong attention to detail; Microsoft PowerPoint/Excel/Word; excellent written/verbal communication; manage competing priorities.

Preferred:

• Experience with Pristima, electronic laboratory notebooks, Veeva, LIMS, Empower.
• Experience leading/supporting US/EU health authority inspections.
• Superior collaboration.

Skills:

• Audit Management, Collaborative Leadership, Project Leadership, Quality Assurance Systems, Quality Oversight, Regulatory Compliance

Benefits (explicitly stated):

• Medical/dental/vision insurance, retirement (401(k)), paid holidays/vacation, compassionate and sick days.