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 Manager, you can expect to serve diverse and sophisticated Life Sciences clients across the biotech, pharmaceuticals, medical devices 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 Manager to manage 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. In addition to delivering professional services, you will have the opportunity to participate in and manage business development activities on strategic and global priority accounts.
Your key responsibilities
We help our clients across multiple Q&C 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:
- Effectively manage engagements and motivate teams with diverse skills and backgrounds, fostering an innovative and inclusive team-oriented work environment
- Foster strong relationships with client personnel at appropriate levels to help them effectively address their complex issues. Consistently deliver quality client services and high-quality work products within expected timeframes and on budget
- Demonstrate in-depth 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
- Cultivate and manage business development opportunities. Understand EY and its service lines and actively assess/present ways to serve clients
Skills and attributes for success
- Leadership in deploying Q&C solutions that support regulatory compliance while supervising and managing local and global teams (sometimes virtually)
- Confidence in your Q&C Life Sciences industry experience and reputation as an authoritative Q&C expert
- Energy, ambition, and communication across functions (internal and external to EY) to identify and follow through on opportunities
- Focus on the importance of coaching and developing teams and colleagues, by assessing their ideas and giving them the knowledge, skills and opportunities they need to deliver
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 5-6 years of related work experience
- 3+ years of related work experience in Life Sciences
- Strong understanding of applicable regulatory requirements such as 21 CFR Parts 11, 210, 211, 610, 820, HIPPA, and more
- Industry related certification (e.g. RAC, PMP, CISA, RICS); non-certified hires are required to become certified within 1 year from the date of hire
- Prior relevant advisory consulting experience
- Strong skills in project management (accountability for schedules, deliverables, priorities and dependencies, progress updates etc.), team management, and client service
- A willingness to travel to meet client needs; travel is estimated at 80%
- A valid driver's license in the US and a valid passport
Ideally, you'll also have
Experience in one or more of the following:
- Quality and regulatory operations and developing, improving or remediating Quality management systems for Life Sciences organizations, performing or managing responses to /health authority (e.g. FDA) observations, implementing LIMS and other QMS systems. Experience managing Warning Letter or Consent decree remediation a plus
- Developing cGxP audit plans, assessments and reports. 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
- Computerized System Validation (CSV) and testing in a validated environment with real-life knowledge of Software Development Life Cycle requirements, different (agile, waterfall), and testing automation (i.e. Quality Center, ValGenesis) and issues tracking tools (i.e. Atlassian tool sets (JIRA)
- End-to-end management of clinical trials including study design, study coordination, patient data acquisition and management; close out; external data management, regulatory reporting and risk-based monitoring
What we look for:
We are interested in Quality and Regulatory Affairs Life Sciences professionals with an in-depth 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, both pension and 401(k) plans, a minimum of 15 days of vacation plus ten observed holidays and three paid personal days, and a range of programs and benefits designed to support your physical, financial and social well-being. Plus, we offer:
- The opportunity to manage a portfolio of talent within a designated service line
- A collaborative environment where everyone works together to create a better working world
- Excellent training and development prospects, both through established programs and on-the-job training
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.