VP, Quality Assurance

We have a rare opportunity for a VP, Quality Assurance to join our A-team. In this role you will be responsible for leading the strategic vision, operations, and financial health of the Quality organization. You will be responsible for planning, preparation and execution oversight of customer audits/inspections. You will lead approaches for quality KPIs/metrics and other activities in accordance with the standard operating procedures, regulatory guidelines, executed client contract and the clients’ expectations. You will take part in the the company Leadership team.At the company™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. Key responsibilities:Lead to identify, develop and implement the business strategy for the Quality department.

Develop and agree upon operating procedures / business processesHead over (executive and senior) management team meetingsReview audit reports (e.g., process, project, vendor), as applicableMaintain and develop organizational culture, values and reputationReport to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department. Support regulatory authority inspections as neededRepresent Quality organization in key meetings (e.g., Monthly Business Review, Board).

Monitor and assure client satisfaction on existing projects for the Quality departmentIdentify key accounts and maintain strong long-lasting relationships to win new and repeat businessWe're looking for someone with:Life science, healthcare and/or business degreeMinimum 15 years of relevant work experienceMinimum 12 years of experience in drug development and/or clinical researchThorough knowledge of ICH-GCP (R2), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirementsProcess orientedStrong analytical skillsDecision-making capabilitiesCritical thinking skillsManagement skills including, but not limited to, oversight of teamsRepresentative, outgoing and client focusedAbility to work in a fast-paced challenging environment of a growing companyStrong leadership skillsExcellent

presentation and networking capabilitiesExcellent organizational, negotiating and financial skillsStrong Business AcumenBenefitsCompetitive salaries and a comprehensive benefits packageDepartmental Study/Training for furthering professional developmentMentoring opportunitiesInternal growth opportunities and career progressionFinancially rewarding internal employee referral programEligibility for our internal employee recognition programs for going above and beyond on projectsEligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employeesAbout the companyOur mission is to help bring new therapies to light. When you work at the company, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

Together we SHINE. find more information about our values. Disclaimers:*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.