Sr Manager, Audits & Inspections - Quality Systems & Compliance

Work Schedule

Environmental Conditions

Job Description

A Senior Manager, Quality Systems & Compliance–Audits & Inspections is responsible for the quality oversight of the Client audit and Regulatory inspection programs. The Senior Manager will ensure expectations, and regulatory compliance to the following guidelines:  21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10. The Senior Manager leads the quality compliance, manages internal and external audits, and ensures inspection readiness for regulatory agency reviews. The Senior Manager oversees cross-functional audit and inspection readiness by coordinating mock inspections and coaching subject matter experts.  This role is a people leader role that manages direct reports at different organizational levels.

Key Responsibilities

• External Audit Preparation & Execution: Oversee scheduling, hosting, and responding to external client audits serving as the primary point of contact for prospective and existing clients requesting audits.
• Inspection Readiness & Execution: Plan, execute, and manage mock and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA.
• Documentation & Record retention: Ensure critical documentation is appropriately documented and stored to support client audits and regulatory inspections.
• CAPA Management: Coordinate and oversee review and response to audit/inspection observations including tracking the implementation and effectiveness check of assigned corrective actions and preventive actions assigned to address compliance gaps and prevent recurring issues.
• Communications: Utilize effective communication channels, tools, and resources to ensure appropriate awareness, coordination, and cross-functional support for client audits and regulatory inspections.
• People Management: Lead, mentor, and coach functional and support personnel on quality matters involving the Audit & Inspection program.  Ensure all personnel complete their training to maintain compliance.  Encourage teamwork among personnel to enhance cross-functional skills.

Minimal Requirements

• Education: Bachelor's degree in a scientific, information management, engineering, or related field.

• Experience: At least 7 years of supervisory or managerial experience with direct reports
• Experience: At least 10 years of experience working within the pharmaceutical or medical device industry
• Experience: At least 7 years of experience working in quality assurance and/or quality systems within the pharmaceutical or medical device industry.

Skills:

• Strong working knowledge of 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10
• Excellent communication and interpersonal skills with the ability to collaborate cross-functionally and communicate complex quality concepts to stakeholders at all levels
• Strong problem-solving skills with a proven track record in issue resolution
• Proficient in electronic quality management systems such as  Documentum, Veeva Vault, and TrackWise
• Strong organizational and time management skills to meet critical business and functional timelines
• Detail oriented with keen eye for identifying process improvement opportunities
• Strong relationship-building skills with the ability to work effectively in team environments across all organizational levels