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Senior Quality Specialist, Quality Excellence

Company: Merck KGaA
Location: Rockville
Posted on: September 13, 2020

Job Description:

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Senior Quality Specialist, Quality Excellence Your Role:

As a Senior Quality Specialist in the Quality Excellence function, you will be responsible for activities that drive global Quality improvement. These will include activities such as driving inspection readiness, global simplification and standardization projects, authoring, reviewing and approving controlled documents to comply with appropriate regulations. Reporting to the Head of Quality Excellence, you will also play a key role in influencing and collaborating with stakeholders across multiple geographies, ensuring alignment and participation in these activities to deliver robust global implementation plans.

In addition to routine quality activities in a GXP environment, and as part of the Quality Excellence team, you will also:

Provide global support for regulatory inspections (including pre/post activities)

Drive standardization practices across the organization and champion procedure/process simplification

Conduct laboratory inspections to include inspection readiness, commissioning and/or internal audits

Champion the use and implementation of electronic records & other digital solutions

Provide quality direction and support for initiatives driven by Quality Excellence

Ability to travel (up to 20%) to other PSS sites located in US, EU and APAC

Who You Are:

Minimum Qualifications:

Bachelor’s degree in a scientific or technical discipline (i.e. Biology, Biotechnology, Chemical Engineering, etc.)

4+ years’ experience working in a cGMP Quality role

Preferred Qualifications:

Track record of quality improvement and execution

Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity etc.)

Previous 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.

Previous experience of driving/leading projects in a global environment

Demonstrated proficiency in communication, written/verbal and interpersonal skills

Advanced degree (i.e. Master’s degree) in a scientific or technical discipline (i.e. Biology, Biotechnology, Chemical Engineering, etc.)

Knowledge of Project Management tools and track record of successful project implementation

RSRMS

Job Requisition ID: 208884

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.

Keywords: Merck KGaA, Rockville , Senior Quality Specialist, Quality Excellence, Other , Rockville, Maryland

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