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Job Description

The mission of our company’s Research Laboratory Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research Laboratory Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).

The Senior Specialist of Compliance and Quality Systems position reports to the West Point Site Director of Compliance 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 Audits as needed. 
  • Support 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 appropriate Science (chemistry, biology, biochemistry, microbiology), IT or Engineering discipline. 
  • Preferred: Advanced degree. 

Required:

  • Minimum 5 years of experience in Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics or related industry. 
  • Background within Biologics, pharmaceutical or related industry in Quality Assurance, Quality Control, laboratories, manufacturing, research and development, supply chain, facilities and engineering. 
  • Extensive knowledge of FDA and EU GMP regulations as well as ICH guidelines. 
  • Demonstrated knowledge and direct experience with developing and establishing Quality Systems and GxP compliance within a regulated environment. 
  • Experience leading internal and external audits. 
  • Experience leading and/or supporting US and EU health authority inspections. 
  • Extensive experience using electronic quality systems to monitor, report and track quality tasks and key performance indicators. 
  • Excellent attention to detail. 

Preferred:

  • Familiarity with R&D or clinical supply areas and processes. 
  • Strong leadership skills for the ability to lead cross-functional teams. 
  • Superior collaboration and teamwork skills. 
  • Ability to train peers and stakeholders in audit and inspection tools, processes and procedures. 
  • Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines. 
  • Biologics and Vaccine manufacturing experience, knowledge of cell banking requirements and guidelines. 
  • Proficient in Microsoft Office (PowerPoint, Excel, and Word). 
  • Excellent verbal and written communication and presentation skills across all levels. 
  • Prioritize and manage multiple priorities and projects independently. 
  • Understanding of lean sigma principles and tools. 

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.

GRACSJOBS

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA 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.

Learn more about your rights, including under California, Colorado and other US State Acts

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, generally Tuesday, Wednesday and either Monday or 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 presence. This 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”.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Read Full Description
Confirmed 3 hours ago. Posted 2 days ago.

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