Senior Specialist, Technology | Global cGMP & Compliance Auditing

Job Description

The GMP Computerized Systems Sr. Audit Specialist will perform internal and external (vendor) audits as required by compliance exposures and business drivers. This role will drive continuous improvement by proactively identifying and auditing manufacturing computer systems that potentially affect patient safety, product quality, and data integrity. Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, and global regulatory guidelines as appropriate.

The Senior Audit Specialist is responsible for achieving and maintaining qualification / certification status through robust training and continuing education programs to enable conducting computerized system audits of Human Health, Animal Health and Consumer Care Sites, Contracted facilities, Distribution Centers, Business Partners and Suppliers. Responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes. The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, GMP documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.

Responsibilities

• Schedules and performs assigned audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, CAPA receipt) meet established expectations

• Conducts computer system audits of GMP systems/operations to ensure compliance with prevailing regulatory laws and company policies through the computer system life-cycle

• Conducts remote assessments and on-site vendor audits in support of the procurement and life-cycle monitoring of computerized system software and third party IT services

• Responsible for the audit planning, audit execution and formal reporting of all audit results to the responsible management

• Presents the results of audits to senior site and divisional management, including practical recommendations to address identified risks, requiring strong negotiation and influence skills

• Supports the annual development and maintenance of a risk-based audit plan/schedule including scope definition

• Continues to advance and develop knowledge in relevant subject area(s) and expand breadth of knowledge in relevant technical areas

• Leads and manages computerized system audits, providing mentoring to junior audit staff as appropriate

• Monitors trends, identifies compliance issues and determines opportunities for quality improvements within customer areas

• Maintains a broad based expertise of cGMP's, our Company's Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the utilization of computerized systems in the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances

• Limited supervision required in day-to-day activities

Education Requirements

• At least a Bachelor's degree in science, engineering, or related area of study.

Experience and Skills

Required

• At least 5 years of relevant work experience Pharmaceutical/Biotech industry.

• Quality compliance in an EU/FDA regulated industry

• Conducting computerized systems audits of external IT suppliers and internal manufacture ring

• Strong and instinctual compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines

• Work independently with limited supervision in a virtual-management environment

• Strategic, ethical and accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization

Preferred

• Five years in a customer relationship or IT project management role

• Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas

• Lean six-sigma belt | Demonstrated process improvement experience

• Development, implementation and optimization of IT tools to deliver business outcomes/impact

• Change agent and able to adapt in a dynamic environment

• CISA, CSSIP certified

Travel Requirements

• Approximately 25%

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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., Kenilworth, 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.

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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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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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Requisition ID:R131963