Director, Quality Assurance & Regulatory Compliance

Director, Quality Assurance & Regulatory Compliance

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We're fueled by our vision to create a healthier world. Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

Job Description

The Position : The Director, Quality Assurance & Regulatory Compliance is responsible for establishing strategies, planning and development of quality and regulatory compliance processes and procedures. Ensuring that EVERSANA is compliant to all applicable federal, state, and local regulations and standards, with a focus on Quality & Regulatory. They will be responsible for managing and directing the activities of the Quality & Regulatory Departments to ensure that the Company's processes and services comply and meet the regulatory requirements, with a focus on quality standards.

Essential Duties and Responsibilities : Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by :

Quality Responsibilities :

• Oversees Quality Assurance, setting quality goals and objectives consistent with established business unit and management goals, as well as FDA / DEA, State Boards Pharmacy, Accredited Bodies, GDP and ISO Quality Standards, as applicable.
• Promotes the development of a company-wide culture of quality awareness and understanding of the key elements related to quality system and regulatory compliance requirements.
• Serves as the Quality management representative for regulators, notified bodies and customer audits.
• Maintains knowledge of existing and emerging quality standards, regulations and guidance documents, as they pertain to Ripple products. Interprets changes to rules and standards and ensures that they are communicated through corporate policies as well as in Supplier Agreements.
• Supports and has ownership of audit processes for Supplier Qualification and Maintenance. Works cross functionally, in-house, and externally, to facilitate the Supplier Selection process.
• Has extensive experience in the selection and qualification of GxP suppliers and the transferring to GxP responsibilities as well as preparing, reviewing, and approving the corresponding quality agreements.
• Works with SMEs in specific disciplines, both in-house as well as consultants, as needed to ensure expert technical review of controlled documents.
• Reviews and approves controlled documentation related to GxP activities outsourced to Qualified Suppliers, including deviations, OOS investigations, CAPAs, risk assessments, etc.
• Creates a quality documentation system by writing and updating quality assurance procedures.
• Supports Qualified Suppliers in the development of protocols for test method validations, design and process verifications and validations, biocompatibility, sterilization, shelf life, stability, and risk management to ensure compliance.
• Develops the Quality Assurance Unit by recruiting, selecting, orienting, and training QA staff.
• Ensures quality by planning, monitoring, and appraising job results.

Regulatory Responsibilities :

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

People Leader

People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values. In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities :

Expectations of the Job :

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

Qualifications

Minimum Knowledge, Skills and Abilities : The requirements listed below are representative of the experience, education, knowledge, skill and / or abilities required.

10+ years of experience including Quality and Regulatory Compliance.