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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in drug development and clinical research, with a strong focus on quality management systems and regulatory compliance. Proven ability to lead strategic initiatives, manage teams, and maintain client relationships in a fast-paced environment.
Highest-signal resume keywords
Drug Development ExperienceClinical Research ExpertiseICH-GCP KnowledgeRegulatory Compliance 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 SystemsAuditingRegulatory GuidelinesKPI DevelopmentProcess Improvement
Soft Skills
Analytical SkillsDecision-MakingCritical ThinkingNegotiation SkillsClient Focus
Industry Keywords
Life ScienceHealthcareFDA RegulationsGDPR Compliance21 CFR Part 11
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
- Head 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
- Take part 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