Quality Control Lead: Global Projects & Process Improvement

ALMAC Group; Souderton (Montgomery County); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Vision & Dental benefits from

20 days PTO per year

12 holidays

Disability & Life Insurance

401k company contribution

Professional development programs

Job summary

Almac Group in Souderton, PA is seeking a Quality Control Technical Lead to act as the Quality SME on local and global projects, guiding changes in processes and risk assessments within the Quality department. You will work with sponsors and stakeholders, lead change control, generate validation documentation, and ensure timely deliverables while maintaining cGMP compliance.

This senior role partners with global Quality Management and SOP teams, offering growth opportunities in drug development

Qualifications

• HS Diploma or Equivalent required.
• 5+ years pharmaceutical experience with HS Diploma or equivalent.
• 3+ years pharmaceutical experience with Associates Degree.
• 1+ years pharmaceutical experience with bachelor's degree.
• Knowledge of Current Good Manufacturing Practices (cGMP).
• Working with Quality Systems.

Responsibilities

• Act as the Quality SME on local or global projects and provide Quality input to requirements and validation documents.
• Lead implementation of new processes or significant changes within the Quality department and manage risk assessments.
• Capture decisions and report project status to Quality Management.
• Identify impacts and compliance risks and highlight to the project team.
• Ensure deliverables are completed in a timely manner.
• Create/update SOPs and educational materials in collaboration with department SMEs.

Skills

Quality SME

cGMP knowledge

Quality Systems

Education

HS Diploma or Equivalent

Associates Degree

Bachelor's degree

Job description

Almac Group in Souderton, PA is seeking a Quality Control Technical Lead to act as the Quality SME on local and global projects, guiding changes in processes and risk assessments within the Quality department. You will work with sponsors and stakeholders, lead change control, generate validation documentation, and ensure timely deliverables while maintaining cGMP compliance.

This senior role partners with global Quality Management and SOP teams, offering growth opportunities in drug development