Job description

Pharma Life Sciences. Quality Management Systems, Senior Associate

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Job Category:   Health Industry
Line of Service:   Advisory
State & City:   CT-Hartford|GA-Atlanta|IL-Chicago|MA-Boston|NJ-Florham Park|NY-New York|PA-Philadelphia|TX-Dallas
Travel Requirements:   61-80%
Position Type:   Senior Associate
Req ID:   98568BR
PwC/LOS Overview
PwC is a network of firms committed to delivering quality in assurance, tax and advisory services.

We help resolve complex issues for our clients and identify opportunities. Learn more about us at www.pwc.com/us.

At PwC, we develop leaders at all levels. The distinctive leadership framework we call the PwC Professional (http://pwc.to/pwcpro) provides our people with a road map to grow their skills and build their careers. Our approach to ongoing development shapes employees into leaders, no matter the role or job title.

Are you ready to build a career in a rapidly changing world? Developing as a PwC Professional means that you will be ready
- to create and capture opportunities to advance your career and fulfill your potential. To learn more, visit us at www.pwc.com/careers.

PwC Advisory helps our clients with their most challenging imperatives from strategy through execution. We combine the breadth of knowledge of over 48,000 global professionals with deep industry knowledge to deliver custom solutions for our clients. We work with the world's largest and most complex companies and understand the unique business issues and opportunities our clients face.

Job Description
Healthcare is a transforming industry due to legislative and regulatory demands, technology challenges, and societal trends. Our growing Health Industries Advisory team provides strategy, management, technology and risk consulting services to help healthcare institutions around the world to anticipate and address their most complex business challenges.

Our practitioners are supported by a dedicated health research unit, which is managed by a physician partner and provides our clients with cutting-edge intelligence, perspective, and analysis on issues transforming the health industry. Our professionals have deep health industry expertise and include physicians, nurses, system specialists, health policy analysts, actuaries, financial advisors, and data analysts. The Health Industries Advisory team includes the following sectors: Health Services
- Payer/Provider, Pharmaceuticals and Life Sciences
- Suppliers and Innovators/New Entrants.

Our Operations consultants help clients realize competitive advantage from operations. This high performing team translates business strategy into effective operations to drive both growth and profitability. Specific areas of focus include product innovation and development, supply chain, procurement and sourcing, manufacturing operations, service operations, and capital asset programs and operations.

The Pharmaceutical and Life Sciences (PLS) Sector of PwC, which includes the medical device sector, is on a rapid growth path. Within the PLS Sector, our Quality Management System (QMS) practice is one such area of growth.

Our QMS practice focuses on remediating Warning Letters and Consent Decrees from the FDA or other global regulatory Agencies.

In addition, our QMS practice proactively creates effective, efficient and sustainable Quality Systems.

Our success is driven by our ability in driving executive-level ownership of the QMS and in enabling cultural changes, which improves quality and compliance at all levels throughout the organization from the board level to the laboratories and shop floor.

Position/Program Requirements
Minimum Years of Experience: 3
Minimum Degree Required: Bachelor's degree

Knowledge Preferred:

Demonstrates proven thorough knowledge and success, as both an individual contributor and team member, with identifying and addressing client needs: actively participating in client discussions and meetings; communicating a broad range of Firm services; and, managing engagements, including preparing concise, accurate documents and maintaining project economics while maintaining flexibility for unanticipated issues.

Demonstrates proven thorough knowledge and success as a team leader: supervising teams to create an atmosphere of trust and seeking diverse views to encourage improvement and innovation; answering questions and providing direction to less-experienced staff; coaching staff including providing timely meaningful written and verbal feedback.

Demonstrates proven thorough knowledge of Quality Management Systems, preferably within or with the FDA, emphasizing the following areas:

As both an individual contributor and team member assisting with strategy execution and implementation efforts of Quality Management Systems-related client engagements, including these focus areas
new business development; client engagement delivery, i.e. remediating warning letters, consent decrees, and development and execution of effective, efficient and sustainable quality management systems; regulatory agency interactions; and, intellectual property development.

Assisting with the preparation of materials for thought -leadership conferences and roundtables

Demonstrates proven thorough knowledge of pharmaceutical, biotech, medical device and diagnostic businesses, including the following areas:

Insights into the trends and expectations of regulatory agencies;

Guidance on developing effective assessment and remediation frameworks and/or practices;

Experiential guidance, subject matter specialty, and optimized standard industry practices with Quality Management Systems relating to practices involving Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPP), and/or Good Laboratory Practices (GLP)

Skills Preferred:

Demonstrates a thorough level of abilities and/or a proven record of success as a team member: understanding personal and team roles; contributing to a positive working environment by building solid relationships with team members; proactively seeking guidance, clarification and feedback; providing guidance, clarification and feedback to less-experienced staff.

Demonstrates proven thorough abilities and success in assisting with efforts across pharmaceutical, biotech, and / or medical device companies, emphasizing the following areas:

Identifying and addressing client needs with major regulatory agencies (e.g. FDA, EMA, PMDA, etc.)

Developing and sustaining client relationships using networking, negotiation and persuasion skills to help to identify and sell potential new service opportunities;

Preparing and presenting written and verbal materials including RFPs; and,
Assisting with defining resource requirements, project workflow, budgets, billing, collection




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