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Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. 

The Senior Specialist, Biologics/Vaccine Development Quality (BVDQ), Global Development Quality is responsible for quality oversight of process and analytical development, and drug substance manufacturing within the Vaccine and Biologics modalities for pre-commercial products. In preparation for inspections, regulatory filings, and/or clinical supply campaign readiness, will independently perform or coordinate routine and specialized audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company requirements. Independently review and approve production and analytical documentation accompanying the disposition of Cell Bank, Seeds, or Drug Substance lots to ensure conformance to appropriate regulatory requirements. In addition, the Senior Specialist independently proposes solutions to compliance issues or audit comments with client areas. The Senior Specialist may also operationally supervise Development Quality staff, contingent employees or loaned labor.

Primary Assignments:

  • Maintain an expert level of knowledge related to specialized area of technical expertise (such as analytical method / development) or GMP requirements and industry trends as described in applicable worldwide regulations.
  • Advise supported areas on requirements for all assigned project responsibilities as related to quality and our Company standards and communicate project status to management.
  • Independently audit and/or approve GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, facility and/or equipment qualification. Ensure compliance with regulatory and our Company requirements. Issue reports as necessary summarizing deficiencies. Work with areas to resolve any audit findings.
  • Act as Quality representative for in-house or outsourced manufacturing programs. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc.
  • Support of Due Diligence/outsourced programs including travel to other countries (e.g., EU, etc.). Travel may be 5% based upon program needs.
  • Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and quality-related system development and approval.
  • Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance.
  • Independently prioritize activities in support of multiple projects.
  • Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection.

Additional duties may include, but are not restricted to:

  • Independently conduct GMP facility, systems, or procedural audits/inspections of internal support areas and external contractors and suppliers engaged in manufacturing, testing, holding, or packaging of clinical supplies. Ensure compliance with applicable regulations, policies, and procedures. Issue reports summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues/trends.
  • Review and approve production and analytical documentation accompanying the release of Cell Banks, Seeds, and Drug Substance lots to ensure conformance to appropriate regulatory requirements. Audits information supporting retest or re-evaluation dating for clinical supply materials.
  • Represent Development Quality on cross-functional and inter-departmental analytical focused teams by providing quality guidance.
  • Provide technical guidance to senior management in evaluating systems/tools. Assist Development Quality staff and client areas with the technical aspects related to the use of electronic audit tools.

Minimum Education required: 

  • B.S. degree in an appropriate Science or Engineering discipline. Advanced education preferred.

Required Experience and Skills: 

  • Minimum 5 years’ experience in the pharmaceutical/biotechnology industry with B.S. or 3 years with M.S.
  • Demonstrated analytical, problem-solving and communication (oral/written) skills.
  • Knowledge of cGMP and technical aspects of support area.
  • Working knowledge of analytical methods development and testing aspects.

Preferred Skills: 

  • Understanding of drug development life cycle, including process development.
  • Prior background in quality control/quality assurance, auditing, and/or regulatory submissions.

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.

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:

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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.

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

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