Clinical Systems Quality Manager - #604787
Merck & Co., Inc.
Date: 11/26/2021 02:30 AM
City: Rahway, New Jersey
Contract type: Full Time
Work schedule: Full Day
If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law
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 Clinical Systems Quality Manager will be responsible to ensure our our Research & Development Divisions GxP systems are developed, validated, implemented and maintained while following our company standards.
Under the guidance of the leadership within the Business Enablement Organization and in collaboration with Project leads, Technical leads and Business System Owners, CSQM will oversee the quality and regulatory requirements of GxP systems across Global Clinical Development (GCD) and Global Regulatory Affairs & Clinical Safety (GRACS). This role represents the Quality Unit role which is one of the three core roles mandated by corporate policy 13.5. This role has approval responsibility for any changes to the GxP systems within the above organizations.
CORE Accountabilities and Responsibilities
Responsible for 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.).
Assist in 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.
Support periodic review of automated and computerized systems by providing consistent quality guidance across GCD and GRACS business areas.
Remain informed about any 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.
OTHER Accountabilities and Responsibilities
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.
Training: Actively collaborate with our Research & Development Division Learning & Development, Information Risk Management and SDLC Policy Owners within ITRMS area to identify/confirm required training for team members, topics that would benefit from having additional training available and advise the project team members to complete appropriate training.
- Audits & Inspection Findings: Periodically review audit and inspection findings across our Research & Development Division systems to use as a learning opportunity.
Flexibility is required for working during non-business hours to support system releases over the weekend or holidays.
- Bachelor's degree in Computer Science, Computer Information Science or related area
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 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.
Requires management and leadership skills, analytical ability, good judgment, ability to multi-task
Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs
Requires experience in training user communities.
Strong verbal & written communication skills
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
- Ability to proficiently interact with all levels of management 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., 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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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