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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in leading quality strategy and operations within the life sciences and healthcare sectors, with a strong focus on regulatory compliance, client satisfaction, and team management. Proven ability to develop and implement business processes, oversee audits, and maintain organizational culture and values.
Highest-signal resume keywords
Quality Strategy DevelopmentRegulatory Compliance (ICH-GCP, FDA, GDPR)Drug Development ExperienceClient Relationship ManagementLeadership and Team Oversight
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management SystemsAudit ReviewKPI DevelopmentProcess ImprovementFinancial ManagementDecision-MakingAnalytical SkillsCritical ThinkingNegotiation SkillsOrganizational Skills
Soft Skills
Leadership SkillsClient FocusPresentation SkillsNetworking SkillsAdaptability
Industry Keywords
Life SciencesHealthcareClinical ResearchDrug DevelopmentRegulatory Authority InspectionsAudit ProcessesSOPsClient ContractsBusiness StrategyOrganizational Culture
About the role
Key responsibilities & impact- Lead, identify, develop and implement the business strategy for the Quality department
- Develop and agree upon operating procedures and business processes
- Lead executive and senior management team meetings
- Review audit reports, including process, project and vendor audits, as applicable
- Maintain and develop organizational culture, values and reputation
- Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department
- Support regulatory authority inspections as needed
- Represent the Quality organization in key meetings, including Monthly Business Reviews and Board meetings
- Monitor and assure client satisfaction on existing Quality department projects
- Identify key accounts and maintain strong, long-lasting relationships to win new and repeat business
- Lead the strategic vision, operations and financial health of the Quality organization
- Oversee planning, preparation and execution of customer audits and inspections
- Lead approaches for quality KPIs and metrics in accordance with SOPs, regulatory guidelines, executed client contracts and client expectations
- Participate in the Allucent Leadership team
Requirements
What you’ll need- Life science, healthcare and/or business degree
- Minimum 15 years of relevant work experience
- Minimum 12 years of experience in drug development and/or clinical research
- Thorough 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 requirements
- Process oriented
- Strong analytical skills
- Decision-making capabilities
- Critical thinking skills
- Management skills including, but not limited to, oversight of teams
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Strong leadership skills
- Excellent presentation and networking capabilities
- Excellent organizational, negotiating and financial skills
- Strong Business Acumen
Benefits
Comp & perks- Competitive salaries and a comprehensive benefits package
- Departmental Study/Training for furthering professional development
- Mentoring opportunities
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Eligibility for our internal employee recognition programs for going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
- Hybrid work policy prescribing 2 days in office per week for employees within reasonable distance from one of our global offices