We are currently seeking a highly skilled and experienced “Sr.QA Manager” to join our team. In this role, you will be responsible for leading the development, implementation, and maintenance of Standard Operating Procedures (SOPs) related to documentation management. The ideal candidate will have a strong background in Quality Assurance, with extensive experience in managing documentation processes and systems.

Key Responsibilities:

• Lead the development, implementation, and maintenance of SOPs related to documentation management.
• Serve as the primary point of contact for all documentation-related inquiries and issues.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
• Manage the Document Management System (DMS) and ensure its optimal performance and functionality.
• Oversee the creation, review, approval, and distribution of all documents, including batch records, forms, job aids, and more.
• Implement continuous improvement initiatives to enhance documentation standards and processes.
• Lead training sessions for staff on documentation procedures and best practices.
• Act as the front room facilitator for quality audits from internal and external parties.
• Provide leadership and guidance to a team of direct reports, ensuring plant coverage and support 24/7.
• Participate in executive-level presentations on project status and daily operations.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, or related discipline).
• Minimum of 7 years of experience in Quality Assurance, with a focus on documentation management.
• Experience working in the pharmaceutical industry is highly preferred.
• Strong understanding of regulatory requirements (e.g., FDA, cGMP) pertaining to documentation management.
• Proven track record of successfully leading documentation projects and initiatives.
• Excellent communication, leadership, and interpersonal skills.
• Ability to work effectively in a fast-paced environment and manage multiple priorities simultaneously.
• Proficiency in Document Management Systems (DMS), preferably Veeva Vault.
• Certification in Quality Management (e.g., ASQ) is a plus.