Senior Quality Assurance Specialist - Compliance and Quality Systems

The Senior Specialist of Compliance and Quality Systems position reports to the West Point Site Compliance Lead in Development Quality. The Senior Specialist is responsible for ensuring continuous compliance of investigational medicinal products with Current Good Manufacturing Practices (cGMPs) and relevant international regulations (e.g., USA, EU). The Senior Specialist will lead and support activities that include, but are not limited to: internal audits, GMP readiness, Health Authority inspections and general compliance initiatives.

Responsibilities include, but are not limited to:

• Lead and support internal audits and assessments to ensure compliance to relevant regulations.

• Ensure compliance with applicable regulations, policies, and procedures.  Issues report summarizing findings and tracks resulting CAPAs to satisfactory closure in order to maintain appropriate risk posture for the site.  Escalate unresolved issues or trends to management.

• Support preparation activities for Health Authority Inspections and our Company Audits as needed.

• Support Good Manufacturing Practice (GMP) readiness activities for new manufacturing facilities, laboratories and support areas

• Maintain a working knowledge of GMP requirements and industry trends as described in applicable international regulations.

• Support the harmonization of procedures and processes that promote, facilitate and ensure compliance with domestic and international regulations and industry standards in support of the company’s objectives.

• Promote a culture of quality and operational excellence. Proactively identify areas for improvement and work across multiple organizations to influence and implement solutions.

• Proactively identify, develop and implement opportunities for work/process improvement and efficiency.

• Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.

Education:

• Required: Bachelor's Degree in Science (chemistry, biology, biochemistry, microbiology), or Engineering discipline  

Required Experience:   

• Minimum 5 years of experience in Quality Assurance, Compliance or Quality Systems in the pharmaceutical, biopharma/biologics or related industry.

• Experience in one or more functional areas such as quality control, quality assurance, laboratories, manufacturing, research and development, supply chain, facilities and engineering.

• Knowledge of FDA and EU GMP regulations as well as International Council for Harmonisation (ICH) guidelines.

• Experience leading internal and external audits.

• Experience supporting US and EU health authority inspections.

• Demonstrated knowledge with maintaining Quality Systems and GxP compliance within a regulated environment.

• Experience using electronic quality systems to monitor, report and track quality tasks and key performance indicators.

• Prioritize and manage activities in support of multiple projects.

• Excellent verbal and written communication and presentation skills across all levels

• Excellent attention to detail.

• Proficient in MS PowerPoint, Excel, and Word.

Preferred Experience:   

• Familiarity with research and development and clinical supply areas and processes

• Understanding of Quality Risk Management and use of Quality Risk Management tools.

• Superior collaboration and teamwork skills

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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

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