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Head, Quality Excellence, Process Solutions Services

Your Role:

As Head of Quality Excellence, you will be responsible for activities that drive the alignment of integrated Quality programs at the global level. Through these activities such as the implementation of a harmonized agency inspection management program across Process Solution Services (PSS), you will be accountable for ensuring aggressive timelines and demonstrating consistent results through improved performance by the reporting of key Quality metrics.

 

Reporting into the Global Head of Quality, you will develop a Global Response Strategy for driving alignment of a multi-site organization for Agency inspection readiness, driving a robust inspection CAPA implementation program, ensuring that responses are globally aligned, implemented and sustained to avoid future observations. This role will work closely with senior Quality management teams at the local site level.

 

In addition, you will also be responsible for establishing and driving key Global Quality Excellence initiatives that impact all PSS sites, leveraging cross functional support and implementing effective execution plans. You will manage a small team to support the Quality initiatives. 

  • Leveraging close collaboration across different geographies (US, EU, APAC) and proactively seeking support from Global Operations, Global Quality and other key stakeholders to get the required input and alignment with Quality strategies
  • Building strong initiatives and execution plans for special Quality Excellence projects
  • Creating and managing effective quality excellence plans to strengthen a Quality culture and align quality improvement activities across different geographies
  • Supporting the Quality organization to ensure alignment of PSS business units with current regulatory requirements and sustaining regulatory commitments across global sites
  • Assist in strengthening key partnerships with customer Quality organizations as well as collaborating with other corporate Quality functions across MilliporeSigma.

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree required with 8+ years leadership experience in a Quality organization, including managing people.
  • Knowledge of Project Management and track record of successful project implementation.
  • 10+ years experience working in a cGMP environment and a track record of quality improvement and execution.
  • Experience of participating in, and knowledge of, global agency inspection programs for the biopharmaceutical or biotechnology industry such as US FDA, EMA, TGA, MHRA etc.  
  • Strong relationship building and negotiation strategies, ability to influence, network, drive and manage change.
  • Understanding of key challenges related to planning and executing projects in different geographic locations.
  • Demonstrated proficiency in communication and interpersonal skills and leading in matrix environments.
  • Ability to travel up to 25% to other PSS sites located in US, UK and APAC.

 

Preferred Qualifications:

  • MBA or advanced technical degree preferred.
  • Previous experience working in an international setting or responsibility for projects in a global environment.
Job Requisition ID:  202698
Location:  Rockville
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

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.


Job Segment: Biotech, Quality Manager, CAPA, Inspector, Science, Quality, Management

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