To ensure our company receives high quality data from the investigational sites around the globe, our systems must be compliant with regulatory requirements and follow our company's SDLC policy. The Associate Director, Systems Quality (AD-SQ) will be responsible to ensure our Company's Research & Development Division GxP systems are developed, validated, implemented and maintained while following company standards.
With minimal guidance from the System Quality Team Lead within the Business Enablement Organization and in collaboration with Project leads, Technical leads and Business System Owners, AD-SQ will work independently to oversee the quality and regulatory requirements of GxP systems across Global Clinical Development (GCD) and Global Regulatory Affairs & Clinical Safety (GRACS) & provide oversight, guidance and support to the Clinical Systems Quality Managers (CSQM) within the Systems Quality team. This role assists in the development of validation strategies to assess/identify areas of risk and establish validation deliverables and release schedule. Collaborates within our Research & Development Division Business Enablement and with partnering areas to ensure alignment of activities to policy to achieve quality goals. Assignments are complex and require detailed understanding of regulations, technology (consisting of highly complex IT solutions, particularly new systems and emerging technologies), and processes to minimize and mitigate risks and to adhere to all applicable regulations.
**_CORE Accountabilities and Responsibilities_**
+ Develop and maintain a subject matter expert level of understanding for our company's Policies, Procedures and Quality Manuals governing computer system validation activities.
+ Identify and incorporate continuous improvements into computer system validation activities and standards. Leverage external affiliations to evaluate current trends.
+ Collaborate and establish relationships with key stakeholders in the Business and Technical Units, including external suppliers.
+ Responsible for independently performing quality activities as it relates to GxP automated and computerized systems compliance within GCD & GRACS. Work with IT, Business System Owners and the user community to provide quality services associated with the validation and compliance of automated and computerized systems (e.g. Change Control, Doc. Management, etc.).
+ Contributes to and guides the development of validation strategy, creation, review and approval of project deliverables to ensure adherence to our company policies and procedures. Act as the quality gate at various project checkpoints.
+ Oversee the completion of quality review activities to ensure they are completed in a consistent, compliant and timely manner across assigned GxP automated and computerized systems.
+ Provide mentoring to teams along with a level of assurance that the deliverables are completed to meet GDP standards and completed according to original plans.
+ Guide project teams to tailor release management and change management strategy/activities based on current processes and the type of system; encourage teams to assess previous release activities to identify any opportunities for improvements; promote use of Digital SDLC.
+ Knowledgeable of various software development models (e.g. waterfall, AGILE, etc.) and capable of translating the required development workflow into a validation package that is compliant with Our Company's SDLC policy.
+ Support periodic review of automated and computerized systems by providing consistent quality guidance across GCD and GRACS business areas.
+ Proactively remain informed about and contribute to updates to applicable policies and procedures to ensure new/modified guidance and procedures are adopted by project teams.
+ Provide communications and presentations on quality topics surrounding computer validation to business and IT project team members
+ For automated and computerized systems, support corporate and other internal audits and regulatory inspections; Assist with identification of root causes, preventive and corrective actions, achievable remediation timelines and proper documentation of actions for system compliance related findings.
+ Represent our company by participating in external collaborations, lectures, etc. pertaining to relevant topics to assist and guide Our Company's implementation and validation of new and emerging technology such as: guidelines on computerized systems and electronic data, Artificial Intelligence Regulations, etc.
+ Contribute to the transformation Our Company's Clinical systems into modern technology and automation, by partnering with key stakeholders in GDMS and assist in ensuring alignments with current regulations and guidelines on eClinical Technologies and AI/ML.
Flexibility is required for working during non-business hours to support system releases over the weekend or holidays.
**Minimum required education:**
Bachelor's degree in Computer Science, Computer Information Science or related area
**Required experience and skills** :
+ Project management experience is preferred.
+ Ten years of overall automated or computer system implementation/validation experience and at least five years of experience in automated or computerized system compliance, project management, systems analysis and systems maintenance/support
+ Position requires experience with an automated or computerized system Software Development Life Cycle (SDLC) methodology in a regulatory environment
+ Requires experience in reviewing validation deliverables.
+ Knowledge and understanding of GCP and Clinical Trial processes as well as quality management and control tools is required.
+ Direct experience in quality management, Auditing and supporting Inspections Experience in Root Cause Analysis, identification and documentation of appropriate corrective and preventive actions.
+ **Communication Skills** : Demonstrates advanced oral and written communication skills to convey and comprehend new and complex information in the manner that is easy to understand.
+ **Problem Solving** : Demonstrates advanced level skills in problem solving using creative and risk-based thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence validation requirements.
+ **Strategic Thinking** : Effectively applies skills to drive or participate in change efforts to enhance processes within our Research & Development Division or across areas within that improve the quality of our computerized systems and /or add value to the business.
+ **Project Management:** Demonstrates advanced ability to multitask and organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
+ **Decision Making:** Effectively applies skills to utilize knowledge, networks and data to support rapid decision making.
+ **Regulatory and Compliance Management:** Demonstrates advanced knowledge of regulations and regulatory trends to ensure our Research & Development Division and appropriate functional areas within our Research & Development Division are compliant with regulations and appropriate procedures and policies and proactively communicates risks and potential options to mitigate risks to the project team to achieve quality outcomes.
+ **Collaboration with stakeholders** : Raise awareness on SDLC compliance related challenges being identified during system development with IT Risk Management & Security (ITRMS) and our Research & Development Division Quality Assurance technology audit teams and obtain guidance to share with IT and business team members. Provide feedback on current processes that would benefit from clarifications and updates; and contribute during review cycle for any process updates.
+ **Audits & Inspection Findings** : Periodically review audit and inspection findings across our Research & Development Division systems to use as a learning opportunity and effectively communicate to stakeholders for awareness and preventative actions.
+ **Leadership** : Ability to interact with all levels of personnel and exert influence to achieve results.
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.
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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.
Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$117,600.00 - $200,100.00
**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.
**Flexible Work Arrangements:**
Remote Work, Work Week
**Valid Driving License:**
**Number of Openings:**
**Requisition ID:** R212511
- Agile Methodology
- Artificial Intelligence
- Change Management
- Clinical Development
- Clinical Trials