Job description

Pharma Quality Management Systems, Experienced Associate

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Job Category:   Health Industry
Line of Service:   Advisory
State & City:   CT-Hartford|GA-Atlanta|IL-Chicago|MA-Boston|NY-New York
Travel Requirements:   81-100%
Position Type:   Experienced Associate
Req ID:   98959BR
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 Year(s) of Experience: 3


Minimum Degree Required: Bachelor's degree


Knowledge Preferred:

Demonstrates some knowledge and/or a proven record of success in Quality Management Systems, preferably within or with the FDA. and pharmaceutical, biotech, medical device and diagnostic businesses
including the following areas:

- Managing engagements, including preparing concise, accurate documents and maintaining project economics while maintaining flexibility for unanticipated issues;

- Supervising teams to create an atmosphere of trust and seeking diverse views to encourage improvement and innovation;

- Coaching staff including providing timely meaningful written and verbal feedback;

- 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;

- Utilizing and applying into projects insights about the trends and expectations of regulatory agencies and developing effective assessment and remediation frameworks and/or practices; and,

- Utilizing and applying into projects 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 some abilities and/or a proven record of success in the following areas:

- 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;

- Identifying and addressing client needs with major regulatory agencies (e.g. Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Device Agency);

- 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 Request for Proposals; and,

- Assisting with defining resource requirements, project workflow, budgets, billing, collection.




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