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Assoc Dir, Quality Management

0-2 years
Not Disclosed
10 Dec. 22, 2024
Job Description
Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, Quality Management
Company: Syneos Health®


About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical affairs, and commercial insights into impactful outcomes, placing the customer and patient at the heart of everything we do. Our Clinical Development model simplifies and streamlines processes to make working with us—and for us—efficient and fulfilling.

With 29,000 employees across 110 countries, we are driven to innovate and accelerate the delivery of therapies that change lives.


Why Syneos Health?

  • Career Growth: We are committed to developing our people, offering career progression, peer recognition, technical training, and a rewarding work environment.
  • Inclusive Culture: Our Total Self culture celebrates authenticity and diversity, fostering a sense of belonging across the organization.
  • Global Collaboration: Join a global team that values diverse perspectives and is passionate about addressing modern market challenges in healthcare.

Key Responsibilities:

  • Consultation & Expertise: Provide consultation on complex GXP-related aspects to project teams and sponsors. Offer expert advice on evolving regulatory requirements and industry developments.
  • Regulatory Support: Lead or contribute expertise to process-related initiatives, audits, inspections, and Quality Issues.
  • Leadership & Decision Making: Lead designated initiatives, make decisions impacting the organization, and support others in resolving problems. Influence innovative thinking across departments and guide teams toward successful outcomes.
  • Problem Solving & Process Improvement: Contribute to identifying, preventing, and solving complex issues while ensuring alignment with business goals. Drive solutions that impact the company and stay up to date with new regulatory and policy developments.
  • Team Leadership: Direct and manage the performance of initiative teams, including resourcing and budget negotiation. May also be involved in strategic planning from a quality or process perspective.
  • Representation & Reporting: Represent Corporate Quality and Syneos Health in various forums, performing quality-related tasks as directed by management.
  • Travel: Travel required up to 25% for audits, inspections, and other quality-related activities.

Qualifications:

  • Education: BA/BS in science, healthcare, or a related field, or equivalent education and experience.
  • Experience: Moderate experience in GXP, regulatory processes, and quality management.
  • Skills:
    • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail.
    • Strong attention to detail and accuracy.
    • Excellent organizational, interpersonal, and team-oriented skills.
    • Ability to act independently and proactively with significant project and customer management experience.
    • Capacity to multitask and meet deadlines effectively.

Additional Information:

  • Compensation & Benefits:
    • Competitive salary and benefits package including health coverage, 401k, and paid time off.
  • COVID-19 Vaccination: Syneos Health strongly encourages employees to be vaccinated, in compliance with local regulations and company policies.
  • Equal Opportunity: Syneos Health is committed to diversity, equity, and inclusion, complying with the Americans with Disabilities Act and applicable local regulations.

Join Syneos Health and help lead the way in quality management, regulatory compliance, and process optimization to improve the delivery of life-changing therapies worldwide!