Pharma Life Sciences - Quality Management Systems Manager

Pwc Denver , CO 80208

Posted 2 months ago

A career in our Supply Chain Management practice, within Operations Consulting services, will provide you with the opportunity to help our clients optimise all elements of their operations to move beyond the role of a cost effective business enabler and become a source of competitive advantages. We focus on product innovation and development, supply chain, procurement and sourcing, manufacturing operations, service operations and capital asset programmes to drive both growth and profitability. You'll be a part of a team that helps organisations in transforming their supply chains into a strategic asset. You'll work with our clients to develop a supply chain strategy, optimise their supply chain footprint and logistics, manage transportation and distribution, and develop an integrated business planning solutions.

Responsibilities

As a Manager, you'll work as part of a team of problem solvers with extensive consulting and industry experience, helping our clients solve their complex business issues from strategy to execution. Specific responsibilities include but are not limited to:

  • Proactively assist in the management of a portfolio of clients, while reporting to Senior Managers and above

  • Be involved in the financial management of clients

  • Be actively involved in business development activities to help identify and research opportunities on new/existing clients

  • Contribute to the development of your own and team's technical acumen

  • Develop strategies to solve complex technical challenges

  • Assist in the management and delivering of large projects

  • Train, coach, and supervise staff

  • Keep up to date with local and national business and economic issues

  • Continue to develop internal relationships and your PwC brand

Job Requirements and Preferences:

Basic Qualifications:

Minimum Degree Required:

Bachelor Degree

Minimum Years of Experience:

5 year(s)

Preferred Qualifications:

Preferred Knowledge/Skills:

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, and development 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)

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.

All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.

For positions based in San Francisco, consideration of qualified candidates with arrest and conviction records will be in a manner consistent with the San Francisco Fair Chance Ordinance.


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Pharma Life Sciences - Quality Management Systems Manager

Pwc