Lead Site Auditor

Job Description

The Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program encompassing the full scope of site operations. Collaboration is required with site leadership regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program apply risk-based principles communicate results to stakeholders and evaluate/verify CAPA closure. Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site.

Position Responsibilities:

• Actively manage mentor and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program

• Function as a change agent related to culture and audit program performance

• Lead change and process improvement initiatives related to Auditing Inspections CAPA and other compliance topics

• Perform routine risk communication pertaining to audits/inspection to Site Regional and Divisional Management

• Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities

• Achieve and maintain auditor qualification status through robust training and continuing education

• Lead training/orientation for new Quality Auditing staff

• Ensure preparation of annual audit schedule using risk-based approaches

• Schedule and perform assigned audits for site program.

• Ensure timelines and quality of content for audit execution (audit pre-work conducting audit issuance of audit report CAPA review and verification) meet established expectations.

• Perform lead and mentor other auditors during site audits; participate in opportunities to audit at regional sites

• Review and approve Audit Reports

• Actively monitor report and trend observations/CAPAs along with standard site audit metrics to Quality Council and Management

• Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program

• Review and ensure CAPA responses to Audits and Inspections are robust

• Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections

• Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations guidance documents and industry standards

• Lead company and site preparation activities for support of regulatory and customer inspections

• Provide compliance advice to site development and commercial product teams

• Supports and continually enhance the ongoing site Permanent Inspection Readiness status

• Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics

Education Minimum Requirement:

• Bachelors degree in engineering Biology Chemistry or related field

Required Experience and Skills:

• Minimum of five (5) years of manufacturing technology laboratory and/or quality operations experience within GMP environment

• GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements

• Knowledge of Quality Systems within a GMP environment

• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders

• Ability to work independently with limited supervision

• Ability to build relationships and influence across disciplines and all levels

Preferred Experience and Skills:

• GMP Audit experience in the pharmaceutical industry (CQA or other certification preferred)

• Experience with leading effective audits and obtaining meaningful audit observations

• Subject Matter Expertise including knowledge and demonstrated application in one or more of the following areas based on site activities; Medical Device/Combination products Biologics Vaccines APIs or Non Sterile or Sterile Drug Product

• Specific technical knowledge in areas pertaining to the hiring site (e.g Quality Systems Manufacturing Testing/Stability Microbiology testing Packaging Distribution Data Integrity Automation)

• Knowledge of QBD development & submission requirements as applicable to site

• Ability to lead motivate develop and mentor other auditors

• Knowledge of and experience in Quality Risk Management methods

• Knowledge of US and European cGMP guidelines ICH and other international regulatory requirements as applicable

• Experience with hosting or participating in Health Authority inspections and/or Divisional audits

• Highly motivated flexible and have excellent organizational and communication skills

• Excellent verbal and written communication skills

• Ability to prioritize and balance work from multiple projects in parallel

Required Skills:

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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