Loading...
Share this Job
Apply now »

We are experiencing a technical issue with the Careers Website. At the moment, applications are not possible. We are working on resolving the issue as soon as possible. Thank you for your patience.

Director/Associate Director, Clinical Quality Management Lead

 

A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
 

Your Role:

Clinical Quality Management (CQM) is an integral part of Strategic Business and Development Operations (SBDO)/Clinical Trial Execution (CTE) and is fully accountable to implement quality planning, control, and improvement practices in a risk-based manner across the clinical pipeline, globally.  The CQM Lead is responsible for the implementation and leadership of Quality by Design and ongoing quality risk management activities at a study level, ensuring that critical to quality factors and quality tolerance limits are proactively specified and important risks to quality are identified, prioritized and mitigated.  The CQM Lead will also lead processes related to risk-based study quality management and oversight, including planning and management of risk-based monitoring and trial oversight.  Additionally the CQM Lead will drive ongoing activities to ensure fit-for-purpose inspection readiness across the portfolio of assigned studies.  The CQM Lead, in consultation with internal Quality Assurance (QA) colleagues, provides guidance on quality principles and performs consistent oversight of adherence to key quality and compliance measures, including KQIs, across SBDO. CQM Lead is the key interface for Quality Management with functions across SBDO, with vendors and CROs and with internal QA functions. CQM Lead ensures that SBDO and vendors are prepared for audits and inspections and that appropriate CAPAs are defined to address key issues identified.  

 

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s or Master's degree in Medical or Life Science (or equivalent industry experience) required, and PhD preferred
  • for Associate Director, expert knowledge of and minimum of 8 years experience in processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment)
  • For Director level, expert knowledge of and minimum of 12 years experience in processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principals and concepts as well as regulatory environmment 
  • Strong understanding of Quality by Design principles, clinical quality risk management processes, risk-based monitoring, and trial oversight as required by ICH E6 R2

 

Preferred Qualifications:

  • Proficient in verbal and written English
  • Cultural awareness
  • Uses appropriate interpersonal styles and skills to influence people
  • Record of successful vendor interactions  
  • Strong knowledge management, project management and change management skills
  • Strong data insights and analytical skills to identify trends and drive quality / process improvements
  • Ability to make risk-based decisions based on a robust benefit/risk assessment
  • Ability to lead GCP inspection readiness activities and support global health authority inspections   
  • Acts as GCP/risk-based quality management Subject Matter Expert for clinical activities  
  • Ability to work in intense, fast paced, matrixed, multinational work environment, fostering collaboration within and across functional areas
  • Ability to work independently on assigned tasks or projects  
  • Capability to perform self-training
  • Ability to accept delegation

 

 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

 

Job Requisition ID:  221640
Location:  Billerica
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Manager, Clinic, Neurology, Oncology, Medical, Management, Healthcare

Apply now »