As the Business Process Owner, the QS Audit Program Lead will have the overall responsibility to develop, implement and sustain the CBM Quality Audit Program ensuring compliance with internal requirements and external GMP regulations. The ideal candidate will be responsible for a high level of understanding of the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determine a quality system’s adequacy and deficiencies. The QS Audit Program Lead will partner with business functions to ensure the successful implementation of the Internal and External Audit Program. This role will require the strategic capability in the form of program development and ownership (including policies, procedures, leading governance, and quality performance monitoring efforts, etc.). In addition to serving as a subject matter expert in these areas, the role will be responsible for maintaining strong, collaborative partnerships with cross-functional and cross-site team members and to create a successful program which would include but not be limited to, Internal, External (Partner), Regulatory Body, and Clinical Audits.
- Responsible for implementation and maintenance of the CBM internal and external audit program
- Responsible for the overall audit processes and assuring consistency across the audit program.
- Develop and maintain the audit program using phase-appropriate Quality processes, with respect to product lifecycle stages from non-clinical development through the life of the program, including commercial launch, and post market approval.
- Ensure Internal Quality Audits are established using a risk-based approach, scheduled, and adhered to.
- Responsible to be the in-room audit manager for all regulatory and external audits.
- Lead, develop and implement regulatory inspection readiness activities, including training site personnel.
- Ensure inspection readiness of all internal and external entities in preparation of competent authority inspections.
- Collaborate with CBM Quality Operations team to assure all applicable groups are inspection ready and operate in a complaint manner with applicable regulatory guidance.
- Responsible for the development and training of a cross functional audit cadre to execute and complete appropriate audit activities.
- Perform periodic reviews of Audit Program documents to ensure the files remain reflective of data/trending signals and ongoing activities.
- Support routine Quality processes such as investigating non-conformances, CAPAs, complaints, other process monitoring activities.
- Assist in risk assessment process and preparation of audit plan that focuses on high-risk areas.
- Establish and maintain strong and efficient communication lines to ensure audit findings are communicated, timely execution of corrective action and implementation of efficiency gains and process improvements.
- Partner with Information Technologies (IT) to define the requirements for Quality electronic systems/databases as the Business Owner, and co-lead implementation of these requirements.
- Act as subject matter expert (SME) of Audit Program, with responsibilities that include defining Key Performance Indicators (KPIs), monitoring system performance, and ensuring compliance to requirements and reporting during QMR.
- Measure and track the results of audits performed through action plan follow-up procedures.
- Manage the development of responses to observations for external inspections and audits.
- Provide recommendations for continuous improvement to strengthen the internal processes and structure.
- Can function as a lead auditor for internal audits and perform audits to ensure compliance to internal and external requirements.
- Bachelor’s degree in a technical discipline (e.g., biochemistry, chemistry, engineering).
- 10+ years of experience in the GMP biotechnology and/or pharmaceutical industry, (preferably both).
- Demonstrated knowledge of Quality Audit Management, continuous improvement methodologies & in-depth understanding of site level products & related processes.
- Experience in participating in regulatory inspections and managing Inspection process.
- ASQ Quality Auditor Certification, preferred.
- Experience with audit management databases/systems.
- Strong working knowledge of regulatory requirements for major government bodies, including FDA (US), EMA (Europe) as well as WHO (World Health Organization)
- Technical experience from working at a manufacturing facility with the ability to understand and interpret regulatory requirements.
- Experience in compliance with quality standards in a Pharma/Biotech industry.
- Ability to utilize Risk Based approaches to prioritize and take appropriate actions.
- Ability to work effectively in a team environment and build strong working relationships.
- Experience in project and/or program management leading cross-functional teams
- Solid analytical skills with the ability to look at the big picture impact.
- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
- Strong organizational skills and the ability to multitask; can set priorities and follow a timeline.
- Collaborates cross-functionally and can work independently with minimal functional oversight.
- Ability to effectively operate across diverse cultures with strong stakeholder management and influencing skills