Director, Quality Assurance & Regulatory Compliance

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. Were fueled by our vision to create a healthier world. How? 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.

THE POSITION:
The VP, 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. 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:

• 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 units 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.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

• Education: Bachelors degree in Life Sciences or a related field.
• Experience and/or Training:
  • 10+ years of experience including Quality and Regulatory Compliance.
  • 5+ 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 aspect of GXP regulations.
  • Ability to manage multiple priorities and meet organizational goals in a fast-paced environment.
• Licenses/Certificates: Two or more ASQ certifications.
• Technology/Equipment: Experience with Microsoft Office Suite, specifically Word, Excel and PowerPoint.
• Continuous Improvement Tools: Six Sigma or LEAN
• Communication Skills: Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
• Innovator: Transforms creative ideas into original solutions that positively impact the companys performance.
• Highly Principled: Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior.

PREFERRED QUALIFICATIONS:

• Education: Masters degree in Life Sciences or a related field.
• Experience and/or Training:
  • 5+ years of recent management experience in a regulated healthcare products environment, with demonstrate experience in all aspects of Distribution & Logistic Quality & Regulations.
• Licensure: Federal and State
• Product Categories: Specialty, Cold Chain, Controlled Substances, Biologics (Tissue Bank), and Combo Devices
• Project Management: 10+ years of project management quality & compliance oversight.
• Performance Indicators: 10+ years of direct Data & Analytical, Trend Analysis, and Establishing KQIs.
• Service End of Quality & Regulatory Compliance: Experience with being a in Life Sciences Service Provider along with providing client regulatory consulting.
• All aspect of GXP regulations.
• Experience preferred with launching a new functions/programs
• Continuous Improvement Tools: Six Sigma or LEAN
• Licenses/Certificates: ASQ Management and Lead Auditor certifications.
• Technology/Equipment: Experience with Microsoft Office Suite, specifically Word, Excel and PowerPoint.

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:
The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

OUR CULTURAL BELIEFS:

Patient Minded I act with the patients best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others.

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

From EVERSANAs inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of ones identity. All of our employees points of view are key to our success, and inclusion is everyone's responsibility.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at [email protected] .

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