Senior Corporate Quality Assurance Specialist

Job Description

MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma s international awards programs for the last three consecutive years.Job Specific Skills:

• Conduct and Support IA plan.
• Understanding of CROs and scientific and clinical data/terminology.
• Proficient in Microsoft word technology and use of templates.
• Ability to support document development (SOPs/ WPs) for QA, IT, PM, HR and Service Lines.
• Excellent ability to multitask, attention to detail, and organizational skills.
• Support timely maintenance multiple QMS trackers, creation & updates to Operations meetings applicable (PowerPoint).
• Excellent communication (written and oral) and ability to create and deliver presentations/ trainings.
• Promote quality, customer satisfaction, and improvement focus among the organization and perform quality improvement and analysis tasks as assigned.
• Promote use of process approach and risk-based thinking among the organization.
• Support External Audits including remote audits and requests for information (RFI) ensuring accuracy of responses pertaining to the IMS.
• Support management of client complaints and nonconformities.
• Support Corrective Action process and closed out in a timely manner per process (OFI, LL mtg, CAPA etc.).
• Support Strategic Business Activities as assigned.

Core Competencies for Senior I/II Level Role

• Level of Independence:
  • Task and project level focus. Independently manages tasks and projects to achieve set objectives. Provides guidance to more junior level colleagues.
• Service Management:
  • Identifies and suggests opportunities for improvement related to Service and/or Service Line at the project level and may contribute to improvements.
• Customer Liaison/ Management:
  • Actively contributes ideas, suggestions and best practices in interactions with the external and internal customers. Frequently supports Business Development activities and customer kick off meetings.
• Impact:
  • Impact on multiple project deliverables within one customer or across multiple customers. Experienced professional who knows how to apply theory and put it into practice with in-depth understanding of the professional field. Independently performs the full range of responsibilities within the service. Possesses broad job knowledge.
  • Analyzes problems/issues of diverse scope and determines solutions. May lead projects or project steps within a broader project or have accountability for ongoing activities or objectives.
• Innovation/ Continuous Improvement:
  • Proactively stays abreast on external industry and technology developments. Able to diagnose internal and customer gaps and propose relevant solutions.
• Discretion/ Latitude:
  • Maintains high level of confidentiality related to customer and internal projects. Exercises high degree of judgment regarding the information that can be disclosed internally and externally.
• Problem Solving:
  • Solves complex problems; takes a broad perspective to identify solutions.
• Communication:
  • Effectively communicates with wide audiences internally: presents at expert webinars and department-wide and/or company-wide meetings.
• Talent Management/ Supervision/ Mentorship:
  • May lead functional teams or projects. Provides technical mentorship and guidance to colleagues within specific area of expertise.
• Quality and Quantity of Work:
  • Produces high quality project deliverables across multiple, high complexity projects with high level of efficiency.

Core Company Values

• Represent self and company in a professional manner and in line with core company values.
• Practice excellent internal and external customer service, communication, and team work.
• Support objectives and improvement efforts within department and organizationally.
• Comply with all applicable policies, procedures, and training requirements.
• Additional tasks as assigned by manager.

Requirements

• College graduate in scientific, clinical discipline or related field/ experience required, Masters preferred.
• Minimum of 5 years experience in quality compliance, auditing or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

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Keyskills :
quality controltest casesqualityreportinginspectionms officeexternal auditmicrosoft wordproblem solvingcustomer servicedrug developmentcorrective actionstrategic businessquality improvement