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Pharmaceutical & Life Sciences Quality Management Systems Manager (5579080)

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Company: PwC

Location: Los Angeles, CA

Date Posted: June 20, 2014

Source: PwC

PwC/LoS Overview:
Are you interested in the opportunity to work for an industry-leading firm that services clients that include the Fortune 500, and will give you the experience and exposure you need to build your career and personal brand? If you are, then PricewaterhouseCoopers LLP (www.pwc.com/us) is the firm for you. PricewaterhouseCoopers LLP (PwC US) helps clients meet the challenges and opportunities of the US marketplace in the areas of assurance, tax, and advisory. We offer the advantage of being part of a global network of firms combined with detailed knowledge of local, state and US national issues. More than 180,000 people in over 158 countries across the PwC network are committed to deliver quality in assurance, tax and advisory services. People across the PwC network share knowledge, experience and solutions to develop fresh perspectives and deliver practical advice.

At PwC US, you will be ...

PwC/LoS Overview:
Are you interested in the opportunity to work for an industry-leading firm that services clients that include the Fortune 500, and will give you the experience and exposure you need to build your career and personal brand? If you are, then PricewaterhouseCoopers LLP (www.pwc.com/us) is the firm for you. PricewaterhouseCoopers LLP (PwC US) helps clients meet the challenges and opportunities of the US marketplace in the areas of assurance, tax, and advisory. We offer the advantage of being part of a global network of firms combined with detailed knowledge of local, state and US national issues. More than 180,000 people in over 158 countries across the PwC network are committed to deliver quality in assurance, tax and advisory services. People across the PwC network share knowledge, experience and solutions to develop fresh perspectives and deliver practical advice.

At PwC US, you will be part of a learning culture, where teamwork and collaboration are encouraged, excellence is rewarded, and diversity is respected and valued. We offer a flexible career progression model that allows for a variety of challenging opportunities throughout your career. We provide unparalleled coaching, mentoring, and career development programs; global opportunities; and state of the art technology-driven methodologies to help you provide quality service to our clients.

From strategy through execution, PwC Advisory helps clients build their next competitive advantage. As the world's second largest global consulting provider, we combine the breadth of knowledge of over 35,000 global professionals with deep industry knowledge to deliver custom solutions for our clients. A long history of working with many of the world's largest and most complex companies means we really understand the unique business challenges our clients face better than most consultancies.

Job Description:
Healthcare is a transforming industry due to legislative and regulatory demands, technology challenges, and societal trends. Our growing Health Industries Advisory practice provides 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 Healthcare Advisory practice is aligned across: Healthcare Provider, Healthcare Payers, and Pharmaceutical and Life Science.

Our Operations consultants help clients realize competitive advantage from operations. This high performing team translates business strategy into operations strategy and transforms operations to drive both growth and profitability. Specific areas of focus include global footprint and network design, product innovation and development, sales and operations planning, procurement and sourcing, manufacturing operations, service operations, logistics, and capital programs.

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 Necessary: 5
Minimum Degree(s) and Certification(s) Required: Bachelor's degree

Knowledge Preferred:

Demonstrates proven extensive knowledge of, and is recognized professionally within industry and regulatory agencies involving, Quality Management Systems, preferably within or with the FDA, emphasizing the following areas:

-Managing the 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, andevelopment and execution of effective, efficient and sustainable quality management systems; regulatory agency interactions; and, intellectual property development.
-Participating and delivering thought -leadership conferences and roundtables, organizing "think-tank"-like discussions around controversial topics in an effort to generate the dialogue needed between industry and the regulators that can lead to potential solutions.

Demonstrates proven extensive knowledge with identifying pharmaceutical, biotech, medical device and diagnostic businesses with potential quality issues and business development targets, including providing 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 proven extensive abilities and success in roles managing large or multiple teams through the design and implementation of people, process and technology changes, including:
-Building solid and collaborative relationships with team members-fostering a productive teamwork environment; leading teams to generate a vision; leveraging diverse views; and helping to develop and grow team members throughout the course of every engagement.
-Exhibiting capability in thought leadership, assisting in new business development and project extensions, including client lead maturation, proposal development, and close;
-Managing and delivering significant business results that reflect strategic and creative thinking, individual initiative and optimized engagement management-executing a business vision and managing complex projects while functioning at the highest levels of client organizations; identifying and addressing client needs ( i.e. building, maintaining, and utilizing networks of client relationships; managing resource requirements, project workflow and budgets); communicating complex material effectively in written and oral formats to various audiences; and, conducting and directing quantitative and qualitative analyses of large and complex data.

Demonstrates proven extensive abilities and success as a team leader, including leading teams to generate a vision, to establish direction and motivate members, as well as create an atmosphere of trust, leverage diverse views, coach staff, to encourage improvement and innovation.

Demonstrates proven extensive abilities and success with managing 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 extensive client relationships using networking, negotiation and persuasion skills to help to identify and sell potential new service opportunities;
-Preparing and presenting complex written and verbal materials including RFPs; and,
-Defining resource requirements, project workflow, budgets, billing, collection.

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