Director, MRLQA GLP

Employer
Merck
Location
United States, US
Posted
April 13 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA007293

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


Essential functions include but are not limited to:  


Leading thought and strategy to define, plan, execute implementation and management of the Quality Assurance strategy within Merck Research Labs (MRL) QA GLP such as Due Diligence and inspection management. Assure we are ready for an evolving model of Research & Development. Work with GLP Head to define strategic direction for quality and compliance in the GLP space to align and assure readiness for GLP modernization.  Collaborates within MRL QA, Safety Assessment Laboratory Animal Research, Pharmacodynamics Pharmacokinetics Drurg Metabolism, Analytical Sciences and with partnering areas to ensure achievement of end to end quality goals. The Lead will educate to ensure quality principles are considered and embedded through the principles of quality by design throughout the drug development process, including risk identification and risk mitigation strategy that is effective and appropriate. Across MRL QA, ensure quality oversight is implemented and quality metrics, including audits, are utilized to inform the business of the state of quality within their functions. The Lead will utilize quality activities, inspection intelligence and risk mitigation plans to assure adherence to Good Laboratory Practice (GLP) in the conduct of GLP studies. In the context of GLP studies, advance the reviews of quality principles and integrity of generated data. Assignments are complex and require detailed understanding of regulations and processes to minimize and mitigate risks such as advancing our Due Diligence approach, proactive inspection strategy management and appropriate advancing of MRL procedures and practices.  Interface with MRLQA for alignment with Technology, Strategy and Business Management including processes. Extensive knowledge of Good Laboratory Practices (GLP), associated guidelines and GLP stakeholder area processes are essential. 


Embed and advance the quality system across MRL making the connections stronger with GMP  and other relevant areas in advancing research.


Primary Activities: 

Primary activities include but are not limited to :

1. Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions and status of competitor projects to effectively develop and advance QA strategies. 

2. Represents QA with GLP and regulated laboratory functions and provides QA strategic guidance.

3. Maintains robust quality oversight plans for GLPQA, contributes to the QA strategy and through collaboration with stakeholders and GLPQA LT, refines and adjusts strategies and plans as needed. 

4. Identifies areas of greatest risk, through intelligence gathering (e.g., data trends, identified quality issues, regulatory intelligence), to proactively and accurately influence risk based QA assessments for implementation of robust mitigation strategies.

5. Lead and manage a range of GLP, Due Diligence, regulated laboratory audits, including complex audits.

6. Interfaces with relevant stakeholders, including regulatory, GLP compliance councils, as appropriate, to provide GLP, industry trend/intelligence and QA expertise.

7. Develops and enhances QA procedures, guidance documents and audit tools to ensure consistent global QA practices. Manage QA advise to stakeholder processes.

8. Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within GLP studies and regulated laboratory activities to appropriate leaders and colleagues.

9. Lead regulatory inspections. Engages in appropriate activities to support product submissions and manage the inspection environment including forming a strategy to proactively prepare QA and stakeholder functions at all GLP sites.

10. Responsible for practical knowledge of current and emerging global guidelines, regulations, relevant regulatory approaches, actions and status of industry standards to effectively develop and advance QA startegies . Responsible for continuous engagement with QA and the Business with regards to Industry trends, FOI communication and comparison to Merck’s posture for potential improvements with timely communications.

11. Independently supports departmental operational activities utilizing advanced competencies, knowledge and judgment; proactively identifies and resolves complex issues using experience and support from the MRL QA GLP leadership team and colleagues within and external to MRL QA, as needed.

12. Serves as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge.  Applies capabilities to enhance quality and builds capabilities of less experienced staff, as appropriate.  Develop and lead educational materials and sessions to further develop competencies or process understanding across MRL QA and partnering MRL areas, where applicable.

13. Lead role with the preparation or review of relevant SOPs or policies relevant to MRL QA GLP  or partnering MRL organizations.

14. Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Laboratory Practice, Good Pharmacovigilance Practice, Good Clinical Practice, Animal Welfare regulations), safety guidelines and company policies and procedures.

15. Collaborate in developing the Audit strategy and plan. Execute audit plan including approx. 20% audit support.  Responsible for global GLPQA team core activity schedule, and implementation in accordance with MRL QA risk-based processes. 

16. Collaborates effectively across areas within MRL QA and partnering organizations to achieve quality goals and understanding of and application of appropriate regulations in partnering MRL areas.

17. Develop and monitor completion of MRLQA GLP priorities in alignment with MRLQA. 


Qualifications

Primary skills include but are not limited to:


1. Collaboration and Partnering:  Demonstrates advanced ability to work in partnership with others (within MRL QA and external to MRL QA) to accomplish quality goals; possesses advanced leadership skills. 

2. Communication Skills:  Demonstrates expert communications skills to convey and receive information.  Demonstrates advanced oral and written communications skills.  

3. Problem Solving:  Demonstrates advanced level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.  

4. Strategic Thinking:  Demonstrates advanced skills to drive change that enhances  processes within MRL QA or across areas within MRL to  improve quality and /or add value to the business.   

5. Project Management:  Demonstrates advanced level ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.  

6. Decision Making:  Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary. 

7. Business Operations/Knowledge of Field: Demonstrates advanced level of knowledge of regulations and business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs. 

8. Regulatory and Compliance Management: Demonstrates advanced knowledge of regulations and regulatory trends to ensure MRL QA and appropriate functional areas within MRL are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.


BS/BA degree in an appropriate science or equivalent field (e.g., Toxicology, Analytical Chemistry, Bioanalysis, etc.)

 

Required Experience and Skills
  • Broad based experience in regulated biopharmaceutical R&D and extensive experience in the applications of Good Laboratory Practices  auditing or quality experience and a thorough understanding of GLPs and international guidelines are required
  • Possess extensive technical knowledge for all areas of GLP study conduct.  5 + years’ experience in working with and directly communicating with management with proven accountability, and  demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
  • Demonstrated teaching and coaching capabilities
  • Proven ability to function autonomously at a lead  level in a matrix model and in a team environment
  • Proven business management capability and experience in the build and implementation of  audit management technology
  • Proven ability to think creatively and to develop and execute strategic plans
  • At least 3 years of experience with GLP Quality Assurance management responsibility with oversight of inspection strategy
  • At least 10 years of experience in the applications of Good Laboratory Practices in Toxicology, Bioanalysis, Clinical Pathology, Pathology or Analytical Sciences
 Preferred Experience and Skills:
  • Overall GLP preclinical study and support functions experience
  • Bio-analysis experience
  • Prior supervisory, integration due to in licensing or Due Diligence experience
  • Experience as a manager of people or team leaderYour role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 
 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Quality Assurance
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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