is currently seeking a Client Audit Manager for our Audubon, Pa location. The for Client Audit Manager Is responsible for managing and hosting client, internal, and Audubon-related vendor audits, ensuring Almac Pharma services meets audit requirements and secures client approval for ongoing and new business.

Responsibilities include but are not limited to:

General Duties (Client, Internal, and Audubon-Related

Supplier/Vendor Audits)

• Serve as the primary contact for audits.
• Review all applicable Quality System records.
• Review previous audit reports and confirm that all prior

observations have been satisfactorily closed.
• Maintain comprehensive knowledge of Almac Pharma Services

policies, procedures, and key business processes, including

relevant updates.
• Document potential issues or observations identified during audits

and keep Management informed throughout the process.
• After each audit, compile wrap-up meeting findings and promptly

communicate outcomes to relevant personnel by email, as

applicable.
• Proactively follow up on observations and CAPAs, providing

support as needed until all responses are received.
• Prepare audit response reports (client and internal) and submit

them to Quality Management for review, as applicable, within

expected timelines.
• Attend client and vendor teleconferences as needed.

Manage CAPAs arising from audits

Client Audits

• Clearly define the audit scope before client audits.
• Request clients to share audit agendas in advance.
• Inform Departmental Managers or relevant staff of any changes to

the agenda.
• Ensure the audit room is ready and technology functions properly

prior to arrival.
• Contact project leads for current business status and ongoing

projects.
• Confirm project staff availability during audit for discussions.
• Prepare relevant information ahead of the audit date.
• Collect documentation requested by the customer promptly.
• Host and facilitate audits, coordinating with internal stakeholders.
• Provide a comprehensive overview to auditors and ensure

support for separate work streams as needed.
• Arrange SME participation to address specific questions.
• Notify Departmental Managers about audit findings and address

issues before receiving the report.
• Update databases and distribute audit observations upon report

receipt.
• Work with area managers and SMEs to collect responses, root

cause analyses and CAPAs for findings.
• Track and verify completion and effectiveness of customer

CAPAs.
• Provide CAPA updates to customers at agreed intervals.
• Compile and approve responses to Client Audit Questionnaires.

• Maintain professional oral and written contact with clients to foster strong relationships

Internal Audits

• Develop an annual audit schedule based on risk and regulatory

priorities.
• Lead audits of GxP, quality systems, operations, and support

functions.
• Prepare clear audit reports detailing findings, evidence, and risks.
• Ensure responses to observations are accurate, include root

cause analysis and effective CAPAs.
• Periodically assess risks to identify high-risk processes and adjust

audit focus.

Vendor Audit (Audubon Service Provider/Supplier)

• Coordinate and execute vendor audits to evaluate adherence to

GMP standards and company quality requirements.
• Develop comprehensive audit reports, ensuring clear

documentation of findings and specified corrective actions.
• Monitor vendors for prompt submission and implementation of

CAPAs.
• Assist in the creation, review, and upkeep of supplier quality agreements

Regulatory Audit Support
• Provide assistance to Quality Management during regulatory

inspections by carrying out front-room and back-room tasks

according to inspection protocols.
• Manage document retrieval, oversee communication, and engage

subject matter experts to deliver responses to inspector requests

promptly, accurately, and in compliance.
• Help with preparing, conducting, and following up on audits,

which includes tracking observations, collecting evidence, and

ensuring thorough root cause analysis and CAPAs when needed.

Quality Metrics and Reporting

• Collect and share Quality KPIs from internal, client, and vendor

audits.
• Evaluate audit patterns to pinpoint ongoing issues and

opportunities for ongoing enhancement.
• Communicate audit findings and data to Quality leadership and

cross-functional teams

Cross-Functional Collaboration and Compliance Support

• Work alongside subject matter experts, operations, and quality

teams to boost compliance and enhance readiness for audits.
• Offer advice on regulatory standards, best audit practices, and

CAPA effectiveness. • Assist with initiatives to continuously improve the Quality

Management System.

Qualifications:

Required Education/Work Experience

Bachelors' Degree in science or technical related field

2 years of experience in hosting and leading audits in a Pharmaceutical Manufacturing or

Packaging environment.
• 3 years of experience in Pharmaceutical or Medical Device quality

Required Knowledge:
• Experience with Microsoft Office applications and electronic quality management systems

(EQMS)
• Knowledge of the regulatory requirements and industry standards for pharmaceutical packaging

processes

Preferred Knowledge:
• ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or other ASQ

Preferred Education

Bachelors' Degree in a scientific discipline

Travel

Local travel for supplier audits

What can Almac Group offer you?

• Medical, Vision & Dental benefits from the 1st of the month following start date
• 20 days PTO per year, accrued monthly following start date
• 12 holidays per year
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Hybrid work available for applicable roles
• Professional development programs/ continuous learning opportunities

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RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV's not submitted through our portal or directly to Hiring Managers will be considered unsolicited, and no fee will be payable. Thank you for your cooperation.