AVP/VP/Global Head Quality Services
Company Description
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. 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.
Job Description
THE POSITION:
At EVERSANA, our Compliance Services team is taking a leading role in helping some of the most scientifically advanced BioPharma, Medical Device and other Life Sciences organizations around the world to innovate novel therapies for rare, ultra-rare and critical therapeutic areas including Oncology, Neurology, Immuno-oncology, Immunology etc and bring them to market. With a commitment to excellence and a client-centric approach, we deliver strategic and operational support to help our clients achieve their business objectives. This is a leadership role within EVERSANA Compliance team reporting directly to the Senior Vice President/President, Compliance Services. This individual will be embraced with the responsibility driving the innovation and expansion strategy of Quality services leading to overall business growth. This person will also collaborate very closely with other leaders within the EVERSANA Compliance Services (Medical Affairs, Pharmacovigilance and Regulatory) to further strengthen the vision of integrated compliance services platform. In addition, this person will also work closely with leaders in Commercial Teams and other Service Lines including Patient services, Market Access, Engage, Field solutions, 3PL, Data & Analytics and Management consulting for identifying and driving newer and integrated opportunities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. EVERSANA customers are working on addressing unmet medical needs using advanced techniques and delivery models such as cell and gene therapies, tissue-engineered products, and combination products, evolving in a complex and dynamic scientific and global regulatory environment. So, it’s an ongoing endeavor at EVERSANA to evolve our business strategy and innovation in a manner that we can constantly deliver value to our customers, create strong competitive differentiation, and thought leadership ultimately leading to client delight and business growth. The key responsibilities of this role are:
- We are seeking an experienced and dynamic individual to join our team as the Practice Head of Global Quality Services for our Life Sciences clients. The successful candidate will play a pivotal role in leading and growing our Quality Services practice, overseeing four key areas: Leadership and Strategy, Practice Development and Business Growth, Service Delivery and Business Operations, and Business Performance Management.
- Leadership and Strategy
- Drive the entire P&L for Quality services business globally.
- Actively drive building and delivering the overall vision of Practice. Proactively work internally and externally to uncover market unmet needs and build right solutions.
- Building the entire strategy for Practice services to create market differentiation and deliver enhanced value to our BioPharma customers.
- Building and executing Practice strategy for driving revenue. Expand Practice into newer areas that are relevant and needed by the industry.
- Collaborate with other Service Lines like Field Solutions, Market Access, Health Analytics to create an overall Quality service package.
- Global Expansion into new markets
- Global Operations/ Delivery Models. Growth Strategy. Helping constantly evolve the operational metrics to better execute the business and anticipate the trends.
- Creating/Driving Thought leadership across Quality Practice via position papers, webinars, conferences, social media, and other channels.
- Building a partnership ecosystem with customers, partners, and other market players to meet business growth objectives.
- Practice Development and Business Growth
- Drive business development efforts to expand the client base and increase revenue for the Practice.
- Identify new market opportunities, stay informed about industry regulations, and assess potential risks to ensure proactive client support.
- Collaborating with commercial teams, understanding the commercial strategy, and providing the required support through participating in overall solution development, responses to RFI/RFPs and building customer proposals
- Ensure alignment between commercial team and Quality team to achieve business unit commercial goals.
- Presenting the solution during bid defense meeting, answering customer queries, and exhibiting an overall thought leadership in the area
- Collaborating with marketing team to develop thought leadership articles, supporting new campaigns specific to Quality services, writing white papers on upcoming trends.
- Collaborating with commercial operations team to provide inputs on customer SOWs.
- Booking/Invoiced revenue evaluation, provide models/commentary of data via bottoms up approach.
- Collaborate with Quality team to drive upsell and cross-sell opportunities.
- Tap into own industry network to drive business growth
- Service Delivery and Business Operations
- Collaborating with Quality Leadership and Quality Consultants globally to ensure seamless execution of day-to-day operations.
- Act as point of escalation and work with internal teams and customers to resolve operational issues.
- Understand client needs and industry trends to develop and deliver tailored solutions that address their specific quality and compliance challenges.
- Work with team to understand their resourcing and other operational needs.
- Global Operations/ Delivery Models Growth Strategy. Helping constantly evolve the operational metrics to better execute the business and anticipate the trends.
- Ensure the delivery of high-quality, value-driven services that meet or exceed client expectations.
- Develop 1:1 relationship with the top strategic customers and act as a coach for the operational team to drive growth within those accounts.
- Support in developing partner ecosystem globally.
- Business Performance Management
- Driving overall monthly operational reporting & dashboards both for business growth as well as business operations
- Take corrective actions to deliver on the P&L goals.
- Build across Service Line collaboration and joint value proposition. Building and driving large deals leveraging most EVERSANA capability
- Identify current pivotal positions and future strategic capabilities and create strategies to build talent development pipelines and retain, engage, and optimize the performance of individuals in those roles.
- Build and develop a high-performance team that lives the EVERSANA values of caring, creativity, commitment, and collaborative behavior.
- Lead the development of a segment culture that lives the EVERSANA values and provides high value to clients and employees.
- Attract, develop, and retain leadership for key segment positions.
- Create manpower plans and manage headcounts at or below budgeted levels.
- Ensure organizational development programs are effective at all levels.
- Interface effectively with shared functions such as Legal, Finance, QNRA and Human Resources
- Ensure company policies are effectively implemented at all locations.
- Provide input in the development/modification of policies and templates.
These results are achieved by:
- Providing overall leadership to the Practice, driving the P&L
- Ensuring alignment of all stakeholders involved in delivering the best experience to our customers through our services.
- Setting clear direction, effective plans, and measurable outcomes
- Ensuring work is accomplished effectively by managing employee performance, work processes and other resources.
- Engaging employees to maximize their discretionary effort.
- Developing a pipeline of excellent talent to fill future business needs.
- Plans, organizes, and coordinates various projects, programs and services.
- All other duties as assigned.
Reasonable accommodation 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:
- Support SVP/President of Compliance Services to oversee the entire business
- Enabling effective collaboration between commercial, Quality team, finance and other teams involved in day-to-day business
- Interview, select and supervise the activities of the department staff; communicate interpret and discuss with team the company policies and procedures.
- 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.
EXPECTATIONS OF THE JOB:
- Travel (20% to 30%)
- Hours (8 Hours per day, 5 days of the 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.
Qualifications
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
- Education – Postgraduate in Pharma Quality related areas or equivalent qualification is a must for this position. An MBA and/or any formal education in understanding and running a business will be added advantage
- Experience and/or Training
- Minimum 20 to 25 years of experience in
- Managing global Quality teams/life sciences services business.
- Vast experience with BioPharma/Medical Devices
- Quality Management/Assurance and Regulatory Affairs
- CMC, IND Filing, NDA Filings, Regulatory/Quality Audits
- Experience with FDA, EMEA/MHRA and other global regulators
- US and International regulatory and GMP requirements
- Quality Management System
- Experience with emerging companies and associated challenges in Quality/ Regulatory
- A strategic SME providing leadership level advise to “C” level in small/mid BioPharma/Medical Devices companies in Quality/Regulatory areas. Working with the Heads of Quality/Regulatory functions in BioPharma/Medical Devices companies for setting up Quality/Regulatory functions or understanding their current challenges and proposing solutions
- A proven leader with vast industry network
- Ability to establish credibility with a variety of audiences and to be decisive
- Strong analytical, numerical, and reasoning abilities
- Exceptional written, oral, interpersonal, and presentation skills including the ability to effectively interface with all levels of management and staff
- Superior management skills: ability to influence and engage direct and indirect reports and peers
- Well versed with the technological advancement across Life sciences industry as well as Quality including advanced data analytics, application of automation and artificial intelligence and data science
- Positive Attitude and Energy- Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through her/his attitude
- 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 company's performance
- Highly Principled - Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior
- Market/strategic analysis - Ability to understand the markets and customers served by EVERSANA and develop appropriate capability and service lines to support market needs
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.
Additional Information
OUR CULTURAL BELIEFS:
Patient Minded I act with the patient’s 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.
EVERSANA is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $200,000 to $280,000 and is not applicable to locations outside of the U.S. The base salary range represents the low and high end of the salary range for this position. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). EVERSANA reserves the right to modify this base salary range at any time.
From EVERSANA’s 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 one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.