Associate Director, Quality Assurance - Site Lead Auditor

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Growth and Improvement minded Quality Assurance Associate Director | Site Lead Auditor that can help drive our Strategic Operating Priorities:

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunities and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Quality Assurance Associate Director | Site Lead Auditor will have leadership responsibility for the site internal audit program encompassing the full scope of site operations. Collaboration will be required with Site Leadership, Regional Compliance Leadership, and Divisional Quality Assurance to ensure an effective site audit program focused on early detection and robust remediation of observations is maintained, with the ability to guide and achieve all aspects of the audit program, apply risk-based principles, communicate results to stakeholders, verify appropriate corrective and preventative actions (CAPAs) are determined, and track commitments to closure.

The position will also take a lead role in hosting Health Authority inspections and internal audits of the site including response writing and audit closeout activities.

Key Functions

• Work objectively and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Site Lead for all GMP related regulatory inspections, including preparation, pre-requests, execution, response writing, CAPA tracking and closeout

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

• Develop annual audit schedule for site using a risk-based approach

• Maintain auditor qualification status allowing direct leadership and participation in internal site audits

• Schedule and perform assigned audits per the designated site program

• Support audits of other sites within the network or suppliers as required (auditor community of practice and guest auditor programs)

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

• Complete routine communications related to audits/inspections to Site, Regional, and Divisional Management

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

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

• Direct site permanent inspection readiness efforts including preparation activities to support of regulatory audits and customer inspections

Education

• Bachelor's degree in Engineering, Biology, Chemistry or related field

Required

• Six years in an Operations, 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

• GMP Audit experience in the pharmaceutical industry

• Experience leading effective audits and obtaining meaningful audit observations

• Direct knowledge and experience in one or more of the following areas: Quality Systems, primary/secondary packaging, release/stability testing, medical device/combination products, biologics, vaccines, APIs, non-sterile and sterile drug product, microbiological testing, distribution, data integrity, automation

• Ability to lead, motivate, develop and mentor a team

• Knowledge and experience with Quality Risk Management methods

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

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

• Highly motivated, flexible, and possesses excellent organizational and communication skills

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

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

Click here to request this role’s pay range.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

Click here to request this role’s pay range.

Search Firm Representatives Please Read Carefully
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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R202741