Assoc. Director, Quality, Trust & Compliance

About Us:

Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia.

Position Overview:

The Associate Director, Quality, Trust & Compliance, reporting to the Vice President, Quality, Trust & Compliance, will be an active contributor to maintaining and improving quality systems to ensure compliance with global regulatory requirements, and ensuring that the quality systems are validated and used effectively to support company quality policy and objectives. They will also serve in the capacity as the alternate Data Protection Officer.

Responsibilities:

• Leads the definition, implementation, and maintenance of standard Compliance processes and methodologies for endpoint products and IRT system. Leads and coordinates the preparation and modification of quality system procedures compliant with respective regulatory standards, such as 21CFR part 11, EU Annex 11 and other applicable standards and regulations. 
• Collaborates closely with Operations, R&D, IT and other Compliance areas to improve adherence to regulations and internal procedures.
• Collaborates with IT to develop an information security and IT risk management program to ensure the integrity, confidentiality and availability of information.
• Overseeing all auditing activities to include internal, customer, and vendor audits in accordance with the established audit schedule or equivalent and applicable organizational processes. This includes supporting auditors in the conduct of audits and when required conduct complex audits and for-cause investigations or ensure peer review audit reports.
• Oversees preparation and hosting activities for third party audits including FDA, Notified Body, corporate and international regulatory authorities’ audits. Leads follow-up efforts.
• Oversees the corrective and preventive action (CAPA) system. Collaborates with other associates to ensure corrective and preventive activities are effective and are managed and processed in accordance with requirements.
• Advise product teams on the regulatory requirements and risks within the product life cycle based upon regulatory guidance’s and global regulations.
• Participate in conduct and review of system compliance assessments, categorization, and regulatory impact assessments, and computer system validations for developing technologies.
• Serve as a point of Compliance leadership contact in developing quality assurance strategies with Clients (Sponsors and CRO), serve as Compliance representation to operational, IT and/or quality governance as appropriate. Act as customers' point of contact for all matters concerning quality assurance to include nonconformities, customer complaints and audits.
• Drive transformational change and improvements with a significant impact to the organization, in a highly complex, rapidly evolving regulated environment. Provides leadership and strategic input to development and implementing company policies, Key Risk Indicators, client service and other quality measures.
• Development, execution, oversight, and deployment of organizational Compliance Metrics / KPIs - health of the quality system.
• Participates in Senior Management Team regular quality reviews.
• Educate the company and employees on important compliance requirements.
• Conduct audits to ensure compliance and address potential issues proactively.
• Performs other duties and responsibilities as assigned.

Education:

• M.S. degree or Bachelor’s degree in a scientific discipline and minimum of 10 years of
• progressively responsible Quality or Technology Compliance experience in a pharmaceutical, biotechnology or related environment
• 5+ years’ experience working with clients or sponsors representing IT process, computer systems validations during qualifications or audits.
• Understanding of IT process, systems validation methodologies, System Development Lifecycle required.
• Certification in Quality Assurance or Regulatory Affairs (RCA) preferred
• Experience in Lean/Six Sigma or other proven improvement methodologies a plus

Experience:

• Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines.
• Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented.
• Experience in developing SOPs in for quality assurance and compliance.
• Experience with creating quality systems in fast paced working environment
• Uses expertise or unique knowledge and skills to contribute to the development of
• company objectives and principles, and to achieve goals in creative and effective ways.
• Can work autonomously to plan, prioritize and organize a diversified workload.

Skills:

• Strong collaboration and development skills.
•  Proactive team player enthusiastic with high work ethic
• PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
• High level of attention to details capable of efficient use of time and project management skills essential.
•  Excellent communication (written and verbal) and presentation skills Ability to lead and coordinate activities of a diverse group of people.

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