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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. location: Cambridge, Massachusetts job type: Contract salary: $60 - 90 per hour work hours: 9 to 5 education: Bachelors responsibilities: Reporting to the Sr. Director of PVQA Quality, R&D Quality (RDQ), the Senior Manager/ Associate Director, PV Quality, will be a key contributor in growing and shaping the company's global R&D Quality Program (GCP/GLP/GVP/CSV). Primarily focusing on PV Quality, the Associate Director will assist and contribute to building RDQ's presence globally, aid in the establishment and execution of PV Quality, support the company's R&D activities both locally and globally. Support Health Authorities Inspections (e.g., MHRA, EMA etc.) and provide oversight of the Pharmacovigilance Quality audit program (e.g., Affiliate/ Vendor/Process Audits, etc.) partnering with RDQ Program Leads. This role will also support other R&D Quality GxP disciplines (GCP, GLP, and CSV) including proactive quality support, identification and conduct of audits, support of Health Authority Inspections and contributions to Regulatory Intelligence activities. The appointee will proactively partner with local R&D operational functions and teams to create a quality culture within the company and help reach a sustained state of inspection readiness. Participate in the development of Pharmacovigilance System support of global R&D activities in the region.Proactively partner with members of global and regional Research and Development organizations to support the successful and compliant execution of R&D activities.Develop and/or provide input in the development of RDQ Quality Audit Schedules and Annual Audit Plans.Provide QA consultation support for CSPV, RA and Medical Affairs/ Medical InformationAssist in the strategic direction for the global and regional program for audits (e.g., Affiliate/ Vendor/Process Audits, etc.) that integrate into the global R&D Quality program and manage the program utilizing an innovative, risk-based approach.Lead complex audits including planning, execution and reporting, and provide guidance to company staff to ensure the proposed corrective actions received from the auditees are appropriate.Provide leadership to interdisciplinary audit teams for complex systems/process audits.Proactively identify and report systematic issues as well as opportunities for process improvements.Provide education, guidance and/or training for PV functional areas.Participate in Regulatory Authority inspections (GVP, GCP, GLP) including inspection preparation training and support; actively support during the inspection and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections.Participate in compliance projects and initiatives.Contribute to the continuing development of a quality culture at the company. qualifications: BS/BA, MS or PhD and a minimum of 12, 10, 9 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.10+ years' experience in Pharmacovigilance QA in a global environment.Strong knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations and local legislation.Experience with Device Vigilance, EU and FDABasic knowledge of relevant FDA, EU, ICH GCP guidelines, and local/regional GVP regulations/legislation.Experience working with CROs, vendors, and relationship management preferred.Excellent auditing skills and ability to communicate significant observations to internal and external business partners in a sound and factual manner.Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.Strong leadership skills with ability to effectively organize and execute tasks.Ability to work both independently and in a team environment.Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.Excellent communication and presentation skills, both verbal and written.Ability to influence and negotiate effective solutions, excellent interpersonal skills.Ability to manage multiple projects in a fast-paced environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment. skills: Pharmacovigilance, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), ICH Regulations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.