Quality Associate Director, Site Lead Auditor Job

West Point, PA, US
June 20 2017
Organization Type
Quality Associate Director, Site Lead Auditor-QUA005996


Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The 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 inspsection 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.

Key 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:

•Bachelor’s Degree in Engineering, Biology, Chemistry or related field

Required Experience and Skills:

•Minimum of 6 years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
•GMP Compliance knowledge and proficiency in interpreting and applying 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
•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, API's 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 Quality by Design (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

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job: Qual Assurance & Ops Generic

Job Title:Assoc. Dir, Quality Assurance

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck