Associate Director, Clinical Quality Assurance

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

In partnership with the Quality Assurance Lead (QAL), the Quality Assurance Specialist (QAS) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. The position will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to GCP in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

The position is accountable for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/vendors/Country Offices (CO). This role is responsible for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our company's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).

Primary activities include but are not limited to:

• Prepares, conducts audits, generates audit reports, communicates results to the relevant management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.

• Activities may include GCP and PV routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party collaborations and due diligence activities.

• Will represent QA as single point of contact and provides guidance for studies in a certain TA or in certain countries.

• Serves as member of project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.

• Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide GCP, PV and QA expertise.

• Contributes to the QA strategy and supports QA goals for the aligned studies/countries in a given TA/Region.

• Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QA assessments and to support the implementation of associated risk mitigation strategies.

• In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.

• In partnership with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements).

• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.

• Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.

• Participates in the development/enhancement of procedures, guidance documents and audit tools to ensure QA consistency globally.

• Provide inspection management support as appropriate.

• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and COs processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our company's policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.

• Acts as a strong technical resource and is called upon to resolve issues based on knowledge of relevant SOPs, GCP, PV regulations and guidelines as well as local regulations.

• Promotes standardization of auditing approach.

• Routinely suggests new audit techniques/aids in areas of technical expertise

• Design and actively participate in special assignments on various project teams and work streams as determined by management.

• Provides training and mentorship to less experienced members of QA staff.

• Ensures the work climate/culture within QA, exemplifies our company's Leadership behaviors.

Education:

• BS/BA degree in a related discipline with 8 years relevant experience in the pharmaceutical industry including conducting a broad range of audits.

Primary Skills:

• Clinical/Regulatory Expertise: Broad and in-depth knowledge of the drug development process, GCP/PV guidelines, and applicable regulations.

• Business Acumen/Attention to Detail: Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.

• Applied Therapeutic Area knowledge: Familiarity with existing company systems, policies and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct, including all projects/premier products.

• Analytical skills: Uses rigorous logic and methods to solve difficult problems with effective solutions.

• Communications: Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.

• Leadership & Decision making: Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.

• Creative Thinking: Strong ability to operationalize ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.

• Teamwork: Strong interactive skills with the ability to work effectively in teams.

• Influencing: Ability to influence and negotiate with key stakeholders.

• Time Management: Ability to multi-task and manage time efficiently and effectively.

• Cultural Agility: Demonstrates ability to work in a culturally diverse environment.

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., Rahway, 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.

Residents of Colorado

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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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.

Residents of Colorado:

Click here to request this role’s pay range.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R203125