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EVERSANA · 8 hours ago

VP, Quality Assurance & Regulatory Compliance

Memphis, TN

Full-time

Onsite

Director/Executive

15+ years exp

EVERSANA is a global leader in commercialization services for the life sciences industry. The VP, Quality Assurance & Regulatory Compliance will establish strategies and manage the Quality & Regulatory Departments to ensure compliance with all applicable regulations and quality standards.

Pharmaceutical

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 of 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

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

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

Establish Quality and Regulatory Compliance strategies and plans that align with Business Units objectives

Interview, select and supervise the activities of the department staff; communicate interpret and ensure that company policies and procedures are followed

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

Promotes the development of a culture of quality awareness and understanding of the key elements related to the quality system and regulatory compliance requirements

Responsible for and overseeing seeing all regulated activities as it relates to meeting federal, state, and local regulations

Enhances key elements of the quality system through continuous improvement in the quality system and documentation, including QMS and implementation and maintenance

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

Responsible for assuring that all Channel Management contracted service comply with the regulation governing the services to ensure no disruptions services

Qualification

Quality AssuranceRegulatory ComplianceGxP RegulationsProject ManagementASQ CertificationsSix SigmaMicrosoft Office SuiteContinuous ImprovementInnovatorHighly PrincipledLeadershipCommunication Skills

Required

Bachelor's degree in Life Sciences or a related field

15+ years of experience including Quality and Regulatory Compliance

7+ years of recent management experience in a regulated healthcare products environment with demonstrated project management skills

Managing Quality and Regulatory Compliance requirements in the pharmaceutical, medical device, biologics industries

Successful track record of implementing and managing quality standards

Leading QA/RA teams to support complex products

All aspects of GXP regulations

Ability to manage multiple priorities and meet organizational goals in a fast-paced environment

Two or more ASQ certifications

Experience with Microsoft Office Suite, specifically Word, Excel and PowerPoint

Six Sigma or LEAN continuous improvement tools

Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate

Transforms creative ideas into original solutions that positively impact the company's performance

Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior