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VP Quality & Compliance Services

Company: Altasciences
Location: Harleysville
Posted on: June 25, 2022

Job Description:

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

JOB DESCRIPTION

Job Title VP Quality, Harleysville & Compliance Services, Altasciences
Department CDMO Services
Primary Responsibilities
The VP of Quality Management and Enterprise Compliance Services is responsible for the following:
Provides oversight of the site business functions including IT, Finance, and Human Resources along with coordination with their corporate counterparts. EVP is further responsible for the overall site quality assurance systems, regulatory filings, licenses and certifications, document control and management. Supervises, trains, and develops site quality assurance department.
Develop and Expand Altasciences Compliance Services offering by:

  • Manage, develop and Implement Altasciences compliance services outsourcing strategy.
  • Implement and Support Business Development and sales initiatives.
  • Secure consolidation, alignment and integration of compliance services post site acquisition as applicable.Reports to Chief Quality and Compliance Officer.

    Tasks Performed
    Quality & Site Management

    • To keep current all federal, state, and local regulatory filings, licenses, and certifications.
    • Provides leadership and mentorship of the QA group. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
    • Ensures quality metrics comply with best industry standards and practices.
    • Maintains effective Quality governance to meet ongoing business and compliance needs.
    • Assess and evaluate existing methods and functions in all areas to identify areas of improvement using IT systems or otherwise.
    • Integrate and coordinate functions of administrative, finance, IT and HR departments with site
    • Develop innovative strategies to enhance performance of the administrative staff
    • Oversight functions of budget and site financial performance.
    • Ensure best corporate practices in implementing administrative and quality activities.Enterprise Compliance Services

      • Overall accountability for the planning and execution of Altasciences contracted compliance services
      • Ensure an effective communication with external and internal customers related to compliance services
      • Manae workload productivity and work quality of assigned team to compliance services.
      • Ensure assigned tasks are completed accurately and within defined performance expectations.
      • Oversee the performance and development of employees via coaching, feedback and career progression management.Communication Internal: Interdepartmental & Intersite External: Clients, Sites, Vendors, Regulatory Authorities
        Qualifications
        • College Degree in a science field or equivalent experience;
        • Knowledge of GXP guidelines and applicable regulations relating to the manufacturing and testing of pharmaceutical products.
        • Experience with regulatory compliance and quality systems.
        • Excellent interpersonal and communication skills,
        • detail-oriented, organized, good initiative
        • Ability to accommodate a flexible work schedule.
        • Software: MS-Office, Outlook, GMP software, Other software elements for different business functions as neededOur team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.

Keywords: Altasciences, Philadelphia , VP Quality & Compliance Services, Accounting, Auditing , Harleysville, Pennsylvania

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