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Senior Specialist small/large molecule quality system

Location: Nijmegen, Gelderland Salary: competitive
Sector: Engineering Type: Contract
  1. Ensure that Quality Bulletin is deployed through all SM/LM sites, ensure its effectiveness, support site variances and ability of site to maintain level of compliance Confirm closure of activities according to plan. Support sites on implementation of relevant Quality Alerts and Quality Bulletins.

  1. Partner with the Global SO and SSO for chapters to proactively identify initiatives and AHQM enhancements. Serve in the role of administrator to ensure a continuous improvement mindset for the AHQM documents. Support Level 3 roll out to SM/LM sites and relative training in myLearning.

  1. Assist in various programs across sites as identified by the AH SM/LM, including, but not limited to:

o Quality and Compliance Excellence (QCE), in particular;

o Support Global SO and SSO for periodic review of the system

o Inspection Readiness Masterplan and review with Site prior to planned inspection, and responses

o Suppot Sites for Divisional audit and responses

  1. Support and contribute to internal compliance forums to identify any emerging trends for continuous improvement in the SM/LM region related to Quality Systems requirements. These activities include: Drive improvements from significant investigations and/or current compliance trends within both SM and LM region.

  1. Support QSC as expert for SM / LM in review of AHQM policies and procedures linked to MMD policies and guidelines, and providing perspective of QSC to sites.

Requirements:

Bachelor's degree in an appropriate scientific or engineering field of study is required. Preferred fields of study include Biology, Biochemistry, and Microbiology. An MBA or other business degree, in addition to the required science or engineering education, is a plus. At least eight (8) years of work experience in a pharmaceutical, biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field. Strong understanding of cGMPs, FDA, EU, USDA and EPA regulatory standards. Strong compliance mindset. Strong lean mindset with MPS/Kata capabilities.

Ability to work within a matrix organization to align on expectations and resolutions.