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Quality Assurance Senior Specialist - United States  

MSD (company)


Posted on : 09 June 2017

Project Description

  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.  
  • Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork. 
  •  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


The position resides in the WP Quality Assurance group.  The primary roles and responsibilities may include:
  •  Coordinating BPDR/FAR activities, including oversight of the BPDR meeting.
  •  Coordinating Fact Finding, Recall Committee, and Market Action activities
  • Performing and coordinating Product Quality Complaint/Adverse Event activities including PQC intake, handling sample returns, investigations, and compilation and analysis of PQC and AE data
  • Working within the Change Control System to ensure requirements are met.  Running IPT Advisory Council meetings.
  • Performing review and approval of automation changes.
  • Providing Quality oversight for Deviation Management Program.
  • Performing review and approval of deviations.
  •  Authoring Annual Product Reviews (APRs)
  • Authoring and managing Quality Agreements (QAs) concerning both other company Sites and external vendors and/or contractors involved in the GMP aspects of the Site
  • Providing Quality oversight of supplier information across all categories of suppliers that service WP
  • Providing Quality Leadership and oversight for risk management across the Site
  •  Performing internal audits.
  •  Participating in regulatory inspections, including facilitating and RMT activities
  • Presenting system overviews to regulators as needed.

Position Background:
  • The Quality Assurance Center of Excellence is the 'Voice of Quality' for the Site and is responsible for providing Quality direction and oversight to the WP Site in the management of those areas assigned, such as general End-to-End Support, Market Actions and Regulatory Communications,  Product Quality Complaints, Internal Auditing, Training, Annual Product Review, Change Control, Inspection Management, Documentation, Manufacturing Batch Records, MES, Quality Planning, and Risk Management in order to maintain compliance with Regulatory requirements.
  • The individual has a key role in the execution and deployment of WP Site and MMD priorities.  
  • The Senior Quality Specialist ensures alignment across the site in the execution of their assigned areas.   
  • The individual is responsible for the maintenance of Quality Systems in accordance with cGMPs and international regulations, guidelines, procedures, and policies.  In addition, the individual is expected to identify and implement continuous improvement activities in their assigned area.
  • The Senior Quality Specialist may participate in or lead key compliance projects at the site aimed at elevating our compliance posture. 
  •  Project Managers are expected to fully manage all aspects of assigned projects, including but not limited to:  quality decision making, stakeholder management, issues identification and resolution, and drive all aspects of project in alignment with established timelines.

Specific Roles/Responsibilities:
  • Lead and facilitate compliance projects to support sustaining and/or enhancing compliance
  •  Lead and facilitate MPS projects to support enhanced efficiency and effectiveness
  •  Support ad-hoc data requests and analysis
  •  Author, review, and approve procedures and other control documents.
  •  Present/discuss GMP deliverables as the SME with Domestic and International Regulatory Agency inspectors and auditors
  •  Assist with aspects of Regulatory Inspections and commitments
  •  Participate in internal audits and shop floor inspections
  •  Execute market actions, Regulatory Agency Communications (FARs, BPDRs)
  •  Performing and coordinating Product Quality Complaint/Adverse Event activities
  •  Process Change Management
  •  CAPA Management
  •  Automation Compliance
  •  Performing gap analysis and remediation
  •  Quality Support/ownership for applicable automation systems
  •  Regulatory surveillance
  •  Conduct training on compliance topics
  •  Execute projects as required by the Associate Director

Bachelors degree in scientific or engineering or related field.

Required Experience and Skills:
  • Minimum 5 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility
  •  Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
  •  Demonstrated self starter with capability to develop innovative solutions to challenges.
  •  Deliver results across diverse areas at Site
  •  Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
  •  Speaks with courage and candor.
  •  Strong written and verbal communication skills.

Preferred Experience and Skills:
  • In-depth working knowledge and application of GMPs.
  •  Proven ability to manage multiple projects simultaneously.
  •  Strong analysis and critical thinking skills are required for this position
  •  Ability to function effectively with ambiguity, changing priorities, and aggressive deadlines.
  •  Ability to make risk-based decisions
  •  Excellent technical writing skills are required along with strong editing skills
  •  Vendor collaboration/relationship, and influencing skills
  •  Ability to drive results and influence others in the areas of data requirements, Regulatory/compliance issues, and timelines
  •  Project management and facilitation skills required to drive projects to completion
  •  Strong business process analysis skills for areas/processes for streamlining, and process re-engineering to enhance value proposition of function.
  •  Ability to work as part of a high performing team:   good collaboration skills, high level of emotional intelligence, ability to maintain objective viewpoints

  • Our employees are the key to our company’s success.  
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  
  • Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.  

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