Job Details
Merck & Co, Inc
Sr. Specialist, Quality Assurance - Biologics/Vaccine Development Quality
Job Description
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.
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.
Education:
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 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.
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 …
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.
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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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Flex TimeShift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R179048