Quality Compliance Audit Manager

Position Summary:

Responsibilities: Essential Duties

• Conduct and document gap analysis to new/revised regulations and provide leadership and project management for implementation, as required

• Maintains and continuously improves B. Braun's Quality Management System.

• Collaborate with sites to establish internal audit schedules and monitor schedule adherence.

• Monitor site quality system certificate expiration and work with the notified body to ensure resolution prior to certificate expiration

• Coach, mentor and train site personnel on the internal and supplier audit program, associated forms and industry best practice.

• Prepare training materials for different regulations and quality systems to ensure compliance requirements are understood at all levels of the organization.

• Serve as quality and regulatory compliance subject matter expert for training execution.

• Perform supplier and internal quality system audits including executing and preparing audit report on a timely basis.

• Maintains comprehensive knowledge of applicable quality and regulatory requirements (FDA, ISO, MDSAP, JQMS, CDMR, etc.) and their interpretation.

• Keeps informed of all existing and new regulatory requirements to provide regulatory compliance expertise to the company by sharing external regulatory and industry trends.

• Provide support, expertise, and direction to sites during regulatory audits and inspections. Develop strategies to ensure successful audit preparation, execution and inspection outcomes.

• Work with sites to prepare responses to regulatory audit observations.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry.

• Influences the development of and drives the application of principles, theories, concepts.

• Determines best course of action.

• Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals.

• May periodically assist in orienting, training, and/or reviewing the work of peers.

• Judgement is required in resolving complex problems based on experience.

• Contacts are primarily with department supervisors, leads, subordinates, and peers.

• Occasional contact with external contractors/vendors.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.

• 10-12 years related experience required.

• Applicable industry/professional certification required.

• Regular and predictable attendance

• Frequent business travel required

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull, Stand

• Frequently:Sit

• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking

• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick

• Constantly:N/A

Salary Range: $140k - $165k

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