Senior Director, Quality Assurance & Regulatory Compliance

THE POSITION:
The Senior Director, Quality Assurance & Regulatory Compliance is responsible for establishing strategies, planning and development of quality and regulatory compliance processes and procedures, insuring that EVERSANA is compliant to all applicable federal, state, and local regulations and standards, with a focus of Quality & Regulatory. 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 ot 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

• Responsible for driving implementation of and continued compliance with global regulatory requirements, interpreting and applying pertinent laws and regulations governing company services to meet business objectives.
• Leads development, implementation, and maintenance of regulatory processes at the business level.
• Supports the development of regulatory compliance strategies.
• Actively works with Business Unit Implementation Teams and/or commercial partners to ensure appropriate planning, tracking, and alignment of regulatory licensure submissions across all facilities.
• Serves as main Channel Management with Regulatory Authorities or, where appropriate, works in conjunction with regulatory consultants or clients to ensure compliance.
• Demonstrates sound understanding of related fields (e.g., controlled substance and cold chain products quality assurance) and ability to solve complex problems in collaboration with colleagues in other functions.
• Monitors the regulatory environment regionally/globally and provides assessments for the impact of new and changing regulations on the business unit’s areas of interest. Ensures new regulations or changes to existing regulations are communicated throughout the organization through policies, procedures, and training (where applicable).
• Represents the Regulatory function on project teams to ensure alignment of regulatory strategy and plans with the team objectives.

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:

• Leadership: Key member of the Senior Leadership Team. Effectively communicates important Quality Assurance and Compliance information to management and other departments of the organization and externally as required.
• Strategy: Establish Quality and Regulatory Compliance strategies and plans that align with Business Units objectives.
• Staffing: Interview, select and supervise the activities of the department staff; communicate interpret and ensure that company policies and procedures are followed.
• Performance and Objectives: Determine job objectives, work methods and performance standards; review performance relative to departmental objectives discussion appraisal with each employee and performance; authorize and communicate salary changes, promotions, transfers, discipline, and discharge and administer all other personnel actions.
• Quality Culture: Promotes the development of a culture of quality awareness and understanding of the key elements related to the quality system and regulatory compliance requirements.
• Oversight: Responsible for and overseeing seeing all regulated actives as it relates to meeting federal, state, and local regulations.
• Quality: Enhances key elements of the quality system through continuous improvement in the quality system and documentation, including QMS and implementation and maintenance.
• Regulatory Compliance: Responsible for regulatory strategy and working with regulatory consultants. Is the front person during regulatory inspections, if applicable. Meets Regulatory requirements and timely responses to Regulatory Letters and Observations, if applicable.
• Client Delight: Responsible for assuring that all Channel Management contracted service comply with the regulation governing the services to ensure no disruptions services.

EXPECTATIONS OF THE JOB:

• Travel (25%)
• Hours (40-hour work week)

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.