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Associate Director, Global Patient Safety Quality & Compliance

Cambridge, MA 02142

Posted: 10/23/2018 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2113

The Global Patient Safety Department (GPS) Q&C Assoc. Dir. is responsible for leading assigned GPS Quality & Compliance activities based on relevant regulations, procedures, and contractual requirements.   Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will implement processes for the management of all GPS controlled procedures, GPS training, GPS files, CAPAs and inspection related activities, as well as leading a QC system for all relevant GPS documents.  The GPS Q&C Assoc. Dir. will design a global GPS training program, including the implementation, tracking, maintenance, and effectiveness checking of all GPS training activities. The incumbent will support the organization and maintenance of a GPS compliance system with metrics.  Proactive and insightful analytical and management skills are required, including an understanding of how to interpret business requirements, make strategy adjustments when necessary and translate them into efficient processes.  Effective communication, project management, and compliance management tracking, reporting, and problem solving will be core skillsets for this role.  

  • Lead GPS process improvements including authoring and updating controlled procedures; maintaining the GPS procedures Index and associated training matrix; leading meetings of subject matter experts for newly authored and revised procedures; and merge procedures, to reduce the total number of procedures for improved efficiency, where possible
  • Represent GPS on cross-functional learning initiatives within company and externally with business partners.  Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure GPS SOP alignment and compliance
  • Serve as the primary point of contact for GPS controlled documents (i.e. SOPs, WIs, etc.) and GPS training and as the subject matter expert for these topics during audits and inspections
  • Lead the development, delivery, implementation, maintenance, and tracking of the global GPS training strategy (training matrix, processes, metrics, effectiveness verifications, process improvements)
  • Develop, provide and track training based on regulatory requirements, applicable internal and external procedures, contractual requirements, scientific best practices to internal and external stakeholders
  • Manage all GPS controlled procedures, training, CAPAs, and a QC system for applicable GPS documents
  • Monitor GPS non-conformance trends and communicate this information to management with proposed remediation actions
  • Support Research Quality Assurance (RQA) by engaging and providing support of the RQA pharmacovigilance/clinical safety audit plan, compliance, audit and inspection activities, inspection readiness and other cross functionality
  • Assist in GPS activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits
  • Track GPS commitments from internal audits, regulatory inspection findings, and CAPAs.
  • Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks
  • Support GPS compliance and alliance activities with vendors and business partners and participate in Pharmacovigilance Agreement creation and revision
  • Contribute to the collection, organization, and presentation of all required global GPS compliance metrics including vendor and business partner oversight metrics
  • Monitor global pharmacovigilance regulatory intelligence to determine impact on company pharmacovigilance quality system and develop strategies to support GPS at the local level

Job Requirements:
  • Bachelor’ s Degree or equivalent work experience in a scientific or technical discipline
  • Must have a minimum of 5+ years of experience in the areas of GXP regulations with 3-5+ years of experience in a quality and compliance role within pharmacovigilance highly preferred
  • Quality and compliance background, preferably related to Pharmacovigilance
  • Demonstrated analytical and process skills and the ability to apply these skills to the PV organization
  • Effective communication, consulting, customer service and problem-solving skills
  • Must be detail oriented, capability to meet deadlines
  • PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required)
  • Excellent time and project management skills
  • Strong interpersonal skills and ability to interact with all levels of the organization and cross-culturally
  • Strategic planning exposure
  • Build positive relationships with regulators, inter and intradepartmental customers, internal and external stakeholders
  • Analyze and interpret regulations and laws and apply to current and future policies and procedures (may include collaboration with other cross functional areas)
  • Global mindset required
  • Demonstrated ability to influence others

Julie Monti
Clinical Recruiter

Julie brings nearly 20 years of experience to her role as Clinical Recruiter for The Steely Group. Throughout her career, she has built lasting relationships and strong partnerships while helping companies build successful teams. Julie is known for her sharp wit, easy smile, sense of humor and genuine interest in people.

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