Client Audit Manager

Almac Group 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.

* 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

* 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

*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.

* 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

* 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.

* 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

crossfunctional 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.

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

* 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

Bachelors' Degree in a scientific discipline

Local travel for supplier audits

Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. 'Partnering to Advance Human Health' is more than just a tagline - it is our way of life.

Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

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.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

EEO is the Law

EEO is the Law GINA Supplement

Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.