QA Manager - Clinical Operations

$90,000 - $120,000/Yr

Piramal Pharma Solutions - Sellersville, PA

Full-time - Mid Level

Sellersville, PA

Chemical Manufacturing

About the position

The Quality Manager in Clinical Operations at Piramal Pharma Solutions is responsible for leading the Quality Assurance department, ensuring compliance with GMP requirements, and driving continuous improvement within the Quality Management System (QMS). This role involves managing projects, training staff, and supporting various quality-related initiatives to maintain high standards in drug development and manufacturing processes.

Responsibilities

• Provide leadership and guidance for the Quality Assurance department.
• Improve core processes and manage projects within the department.
• Ensure staff qualifications in all quality area functions and maintain the QMS to applicable GMP requirements.
• Identify areas for continuous improvement within the Quality department and QMS.
• Evaluate metrics for trends to focus on areas requiring improvement.
• Develop goals for the Quality Assurance team and monitor effectiveness.
• Conduct training for the Quality team and other departments on QMS and GMP requirements.
• Support Quality teams with projects related to commercial and clinical batches, Operational, QC, and QMS projects.
• Lead and support customer requests, quality events, QTAs, and complaints.
• Maintain an electronic documentation control system and ensure all documents are current.
• Act as the Ensur system administrator and support teams as the system SME for CAPAs, change controls, deviations, and laboratory investigations.
• Exhibit strong communication and problem-solving skills while leading the Quality Assurance department.
• Provide guidance and leadership to QA Specialists and input into their performance and goals.
• Support the execution of the audit readiness program for compliance with Customer and Regulatory audits.
• Monitor and review QA systems and procedures for regulatory compliance and quality improvements.
• Participate in site quality and process improvement initiatives and represent QA on site project teams.
• Conduct interviews and hire qualified candidates for technical and support positions.
• Conduct performance and development reviews for QA team members.
• Develop and manage daily work schedules for QA Specialists to meet delivery schedules and needs.
• Ensure QA documentation and batch release are completed by due dates and project timelines.
• Lead the design, implementation, and continuous improvement of QA Operations, Systems, and Compliance.

Requirements

• Bachelor's degree or higher in a relevant scientific quality assurance/technical field.
• 5 years' experience in a manufacturing environment.
• 7+ years experience in a manufacturing Quality role.
• Ability to organize time for multiple tasks including major projects and daily functions.
• Good written, verbal, and interpersonal communication skills.
• Proficient computer skills, including Microsoft Office and Teams.
• Strong leadership skills including building teams, business insight, strategic mindset, problem-solving, and resource management.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance