Join my client's dynamic team as the Director of Quality & Regulatory Affairs, playing a pivotal role in maintaining Quality procedures for regulatory compliance. As a key member of the Senior Leadership Team, you'll lead quality activities, fostering team commitment, and driving revenue goals. This role offers the chance to make a lasting impact on quality operations in a high-growth environment.

Why You Should Apply:

• Lead a dedicated team in Quality Assurance, Quality Control, Stability, and related site activities.
• Drive and sustain positive changes while inspiring and motivating your team.
• Play a crucial role in regulatory inspections, client audits, and the internal/external audit programs.
• Shape the quality budget, implementing cost control and reduction initiatives.
• Collaborate with Regulatory Affairs for USFDA submissions, maintaining existing submissions, and ensuring continued operations.

What You'll Be Doing:

• Leadership: Provide clear direction, maintain resilience, and drive cost control initiatives.
• Release or Reject API/Batches: Maintain decision-making authority and oversee timely batch releases.
• Inspections and Audits: Lead regulatory inspections, audits, and implement corrective actions.
• Investigations, CAPA: Review/approve deviations, investigations, and lead the CAPA program.
• Training: Ensure overall employee training, coaching, and mentoring for quality assurance.

About You:

• Be able to do the job as described.
• Extensive knowledge of GMP requirements, Lean Manufacturing, and Six Sigma.
• 15+ years of Pharmaceutical QA and Regulatory experience.
• Oral solid dosage and CDMO experience highly desired.
• Demonstrated change management and leadership skills.
• Thorough knowledge of Quality Management Systems.

How To Apply: We'd love to see your resume, but we don't need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell us why you're interested. Or, if you do have a resume ready, apply here.

Join us in shaping the future of quality operations - your expertise will make a difference!