Site Lead Auditor
Purpose of Role:
The Site Audit Lead will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. They are and SME & fully understand Our Company Audit Quality System. Collaboration is required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk-based principles, communicate results to stakeholders, and evaluate/verify CAPA closure. Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site.
Activities Within Role:
- Effectively manage the site audit program
- Actively manage, mentor, and support site auditors
- Maintain a process on site to ensure the site is Permanent Inspection Ready
- Function as a change agent related to culture and audit program performance
- Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics
- Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management
- Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities.
- Achieve and maintain auditor qualification status through robust training and continuing education
- Lead training/orientation for new Quality Auditing staff
- Ensure preparation of annual audit schedule, using risk-based approaches.
- Schedule and perform assigned audits for site program.
- Ensure timelines and quality of content for audit execution (audit pre-work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations.
- Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites.
- Review, and approve Audit Reports
- Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management
- Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program
- Review and ensure CAPA responses to Audits and Inspections are robust
- Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections
- Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards
- Lead company and site preparation activities for support of regulatory and customer inspections
- Provide compliance advice to site, development and commercial product teams
- Supports and continually enhance the ongoing site Permanent Inspection Readiness status
- Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics
- Reports to the Quality Assurance Lead and participates as part of the site extended Quality Leadership Team
- Minimum of 7 years Pharmaceutical industry experience within a GMP environment
- Extensive knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements
- Extensive experience in GMP auditing across multiple Quality Management systems in API and Drug Product.
- Experience in GMP auditing of Biologic, Vaccine and Sterile manufacturing facilities
- Experience in GMP auditing of Computerised Systems including automation
- Experience working directly with regulators in audit situations
- Should have good project management skills
- Qualification in lean methodology
- Ability to build relationships and influence across disciplines and all levels
- Should be highly motivated, flexible, and have excellent organisational and communication skills
- Excellent verbal and written communication skills
- Ability to prioritise and balance work from multiple projects in parallel
- Degree or 3rd level qualification (Science, Quality, Engineering).
- Desirable evidence of Continuous Professional Development
- Process and Quality background.
- Demonstrated ability to fully realize improvement initiatives.
- Proven track record of providing independent expertise to Manufacturing functions.
- Demonstrated successes in a team environment, such as project teams, PITs etc., and ability to coordinate, influence and guide team members.
- Demonstrated negotiation skills.
- Strong Analytical problem solving ability and interpersonal skills.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multiple decision makers, auditors, cross functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
- Familiarity with FDA, EU and worldwide GMP regulations/guidelines
- Working knowledge of current Good Manufacturing Practices, regulatory trends, and the application of these activities to process validation, equipment qualification and computing environments.
- Demonstrated coaching skills
- Demonstrated leadership skills
Who we are …
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
As a company we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.