With rapid growth and unique challenges from rapidly evolving health authority requirements in the Quality, Regulatory and Compliance space in the Life Sciences industry, EY is looking for people who understand the challenges of this ecosystem and can focus on improving business performance, quality operations, and drive enterprise transformational strategy in the Life Sciences space.
As Q&C Senior, you can expect to serve diverse and sophisticated Life Sciences clients across the biotech, pharmaceutical, medical device and biologics areas.
The Q&C practice is a strategic investment focus area for EY and rapidly expanding as our Life Sciences clients’ needs grow. For this reason, opportunities within EY’s Q&C practice offer variety, challenge, responsibility and the opportunity to realize your leadership and career progression potential.
We are currently seeking a highly motivated Senior to support client engagement teams and provide advisory services to address key Senior Leadership issues across R&D, supply chain, manufacturing and commercial operations in the following areas: strategy to optimize and transform quality management processes, compliance to existing and emerging health authority regulations both in the US (FDA) and globally, regulatory agency interactions and management of quality and compliance processes.
Your key responsibilities
We help our clients across multiple functional areas with strategy, process and organization optimization and management, technology enablement/implementation, growth strategy, and enterprise transformation. You’ll need to draw upon your industry and client experiences to help our clients implement a proficient design and to effectively manage organizational change in their environment. You will need to:
· Consistently deliver quality client services. Monitor self progress, manage risk and ensure key stakeholders are kept informed
· Effectively work in teams with diverse skills and backgrounds, contributing to an innovative and inclusive team-oriented work environment
· Foster client relationships at appropriate levels
· Demonstrate strong technical capabilities, professional knowledge, and ability to quickly assimilate new knowledge. Stay abreast of new developments in advisory services capabilities, current business and industry trends relevant to our clients.
Skills and attributes for success
· A strong work ethic, self-motivation and progressive thinking that thrives on new challenges
· Strong analytical, technical and problem-solving skills
· Experience in deploying Q&C solutions that support regulatory compliance
· Confidence in your Q&C Life Sciences industry experience as a Q&C professional
· Ability to receive and action on feedback, and self-identify continuous professional development opportunities
To qualify for the role you must have
· A bachelor's degree (preferably in pharmacy, bioengineering, medical technology, biology, chemistry or related technical discipline or management) or a graduate degree and approximately 3 years of related work experience in Life Sciences
· Knowledge of applicable regulatory statutes and requirements such as 21 CFR Parts 11, 210, 211, 610, 820, HIPPA, (and more) and impact on R&D, manufacturing, supply chain and commercial operations
· Industry related certification required (e.g. RAC, PMP, CISA, RICS); non-certified hires are required to become certified within 1 year from the date of hire
· A willingness to travel (including internationally) to meet client needs; travel is estimated at 80%
· A valid driver’s license in the US and a valid passport is required.
Ideally, you’ll also have
Experience in one or more of the following:
· Quality management systems processes/operations, improvements or remediation for Life Sciences organizations, responses to /health authority (e.g. FDA) observations, implementing LIMS and other QMS systems.
· Developing cGxP audit plans, assessments and reports. Supporting assessment, design and implementation of audit, risk management and/or compliance programs including risk governance, risk appetite and tolerance, risk-based strategic/business planning processes, and integration of risk management functions
· Designing continuous process improvement frameworks, tools and templates, and ability to conduct root cause assessment and define corrective and preventative actions (CAPA) in GxP environment
· Software Development Life Cycle requirements, methodology, agile methodology, and real-life experience with Computerized System Validation (CSV) and testing in a validated environment. Testing automation (e.g. Quality Center, ValGenesis) and issues tracking tools (e.g. Atlassian tool sets (JIRA))
· End-to-end understanding of clinical trials including study design, study coordination, patient data acquisition and management; close out; external data management and reporting
What We Look for
We are interested in Quality and Regulatory Affairs Life Sciences professionals with a sound knowledge of the biotech, pharmaceuticals, medical devices and/or biologics industry, and willingness to become proficient in, our standard tools and practices. If you have a genuine passion for helping businesses achieve leading practice risk and quality functions alongside some of the most knowledgeable individuals in the business then this role is for you.
What Working at EY Offers
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. You’ll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being.
Plus, we offer:
Continuous learning: You’ll develop the mindset and skills to navigate whatever comes next.
Success as defined by you: We’ll provide the tools and flexibility, so you can make a meaningful impact, your way.
Transformative leadership: We’ll give you the insights, coaching and confidence to be the leader the world needs.
Diverse and inclusive culture: You’ll be embraced for who you are and empowered to use your voice to help others find theirs.
As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom to make things better. So that whenever you join, however long you stay, the exceptional EY experience lasts a lifetime.
If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible.
Join us in building a better working world. Apply now.
EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, national origin, protected veteran status, disability status, or any other legally protected basis, in accordance with applicable law.