Associate Director – Quality Engineer

Role Summary

Associate Director – Quality Engineer is responsible for providing technical guidance and leadership to the FUME Operations and Facilities Management regarding the quality standards employed to maintain and improve site operations. The area of focus is facility, utility, maintenance, and equipment (FUME) systems for oligonucleotide and small molecule processes.

Responsibilities

• Provide direct quality oversight of production, engineering, automation, and laboratory operations.
• Review and approve documents including, but not limited to, procedures, change control proposals, deviations, equipment/system qualification/validation, analytical methods, and computerized system validations as business QA.
• Provide quality guidance and recommendations regarding manufacturing, materials, utilities, maintenance, and laboratory issues.
• Participate in aberrant data investigations (i.e., deviation investigations).
• Conduct analytical data review including stability data.
• Disposition API Intermediates and raw materials, as appropriate.
• Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems.
• Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems.
• Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), Asset qualification maintenance system strategies and equipment/computer system periodic reviews, as appropriate.
• Conduct gap assessments of global requirements and ensure implementation of the governing standards.
• Participate in and/or lead, support self-inspection activities and regulatory inspections.
• Maintain and improve FUME quality systems.
• Assist business partners in the interpretation of regulatory and corporate requirements.

Qualifications

• BS in Engineering or a science-related field or equivalent experience. Minimum of 8 years of relevant experience required.
• Experience in API manufacturing, QA or Engineering. Must have hands-on experience with oligonucleotide and small molecule processes.
• Experience with system and equipment qualifications
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Knowledge of cGMPs and quality systems.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.

Education

• BS in Engineering or science-related field or equivalent experience.

Additional Requirements

• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.