Lead Auditing QA Specialist

Lonza•Tampa, FL

About The Position

The Lead Auditing QA Specialist plans, organizes, leads, and executes audits to assess compliance with GMP requirements, industry regulations, company standards, and quality systems. The role reviews the organization’s quality management system (QMS), understands its scope, and identifies risks to address during audits. It provides leadership and expertise in GMP compliance and quality, helping ensure activities are performed and documented according to company policies and procedures and applicable quality and regulatory requirements intended to assure product quality, effectiveness, and safety. The specialist develops audit plans, selects audit teams, conducts meetings and interviews, prepares evidence-based reports, and reaches final compliance conclusions. The role supports early detection and prevention of issues, identifies improvement opportunities, and works with cross-functional teams on corrective and preventive actions. It also represents the company during external audits and inspections, serves as an auditing and regulatory subject matter expert, and trains and mentors junior auditors. Lonza describes itself as having more than 30 sites across five continents and emphasizes Collaboration, Accountability, Excellence, Passion, and Integrity. It states that it values diversity and is committed to an inclusive environment for all employees.

Requirements

Bachelor’s degree; a science degree is preferred.
At least 5 years of experience in manufacturing operations, laboratory operations, and/or QA, preferably in pharma or biotech.
Strong understanding of GMP regulations and quality systems requirements for pharmaceutical manufacturing.
Excellent written and verbal communication skills and ability to interact effectively with internal stakeholders and external suppliers.
Strong organizational skills and ability to manage multiple priorities and meet deadlines in a fast-paced environment.

Nice To Haves

Science degree.
Experience in pharma or biotech.

Responsibilities

Lead audits of products and processes to ensure compliance with industry regulations and company standards.
Conduct opening and closing meetings, draft audit objectives and evidence-based reports, and determine final compliance conclusions.
Develop audit plans detailing objectives, scope, criteria, and schedule.
Select audit team members based on audit complexity and required expertise.
Ensure audits meet established timelines and resources are efficiently allocated.
Conduct opening meetings with top management to explain the audit’s purpose and scope.
Lead interviews with key personnel at various organizational levels.
Lead and participate in strategic initiatives to improve compliance with regulatory requirements and standards.
Ensure audits are conducted according to the annual audit schedule.
Serve as an on-site expert in GMP requirements.
Focus on early detection and prevention of issues, followed by correction.
Identify quality and compliance improvement opportunities and develop action plans.
Collaborate with cross-functional teams to implement corrective and preventive actions.
Review and analyze audit findings to identify trends and areas of concern.
Promote continuous improvement, best practices, and quality and compliance initiatives.
Represent the company in external audits and inspections.
Assess the compliance of systems, facilities, and procedures with applicable regulations and specifications.
Serve as a subject matter expert on auditing standards and regulations in the pharmaceutical and healthcare industry.
Train and mentor junior auditors on auditing techniques and best practices.
Independently write SOPs or related documentation as required.
Participate in investigations into root cause, corrective or preventive actions, and impact to product safety, identity, strength, quality, or purity.
Recommend changes to processes and programs.
Perform additional job-related assignments as requested by management, including other tasks assigned by the QA Manager, Compliance.