PwC Pharma, Life Sciences & Med. Device - QMS Sr. Associate in Boston, Massachusetts
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.
To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future.
As a Senior Associate, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to:
Use feedback and reflection to develop self awareness, personal strengths and address development areas.
Delegate to others to provide stretch opportunities and coach to help deliver results.
Develop new ideas and propose innovative solutions to problems.
Use a broad range of tools and techniques to extract insights from from current trends in business area.
Review your work and that of others for quality, accuracy and relevance.
Share relevant thought leadership.
Use straightforward communication, in a structured way, when influencing others.
Able to read situations and modify behavior to build quality, diverse relationships.
Uphold the firm's code of ethics and business conduct.
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
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.
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.