Quality Associate Director, Site Lead Auditor - United States
Want to know company name or location? Company managed [?]
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Quality Assoc. Dir./GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. 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 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, through response writing and audit closeout.
- Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program
- 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 audits 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
- Site Lead for all GMP related Regulatory inspections, including preparation, execution, response writing, CAPA tracking and closeout
Education Minimum Requirement:
Bachelor’s Degree in Engineering, Biology, Chemistry or related field
Required Experience and Skills:
- Minimum of a 6 years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
- GMP Compliance knowledge and proficiency in interpreting and applying regulatory requirements
- Knowledge of Quality Systems within a GMP environment
- Demonstrated ability to establish and maintain collaborative relationships with key stakeholders
- Ability to work independently with limited supervision
- Ability to build relationships and influence across disciplines and all levels
Preferred Experience and Skills:
- Experience leading GMP Audits in the Pharmaceutical industry
- Experience with leading effective audits and obtaining meaningful audit observations
- “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas, based on site activities; Primary and Secondary Packaging and Stability Hub (Medical Device/Combination products, Biologics, Vaccines, API, Non Sterile and Sterile Drug Product)
- Specific technical knowledge based on site activities; Primary and Secondary Packaging and Stability hub (e.g, Quality Systems, Testing/Stability, Microbiology testing,
Packaging, Distribution, Data Integrity, Automation)
- Ability to lead, motivate, develop and mentor other auditors
- Knowledge of and experience in Quality Risk Management methods
- Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable.
- Experience with hosting or participating in Health Authority inspections and/or Divisional audits
- Highly motivated, flexible, and have excellent organizational and communication skills
- Excellent verbal and written communication skills
- Ability to prioritize and balance work from multiple projects in parallel
Travel: Yes, 5 % of the Time