Pharma Life Sciences - Quality Management Systems Sr. Associate

Pwc Dallas , TX 75201

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 Senior Associate, 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 several clients, while reporting to Managers and above

  • Train and lead staff

  • Establish effective working relationships directly with clients

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

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

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

  • Continue to develop internal relationships and your PwC brand

Preferred skills

Preferred Knowledge/Skills:

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; intellectual property development); and,
  • 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).

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.

Minimum years experience required
3 year(s)

Additional application instructions

  • Global LoS:

Advisory

Job Requirements and Preferences:

Basic Qualifications:

Minimum Degree Required:

Bachelor Degree

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 Sr. Associate

Pwc