PwC Pharma Life Sciences Quality Management System Experienced 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.
As an 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 the team in various aspects of the project
Contribute to the development of your own and team’s technical acumen
Keep up to date with local and national business and economic issues
Ensure you are adhering to compliance matters
Work on developing internal relationships and your PwC brand
Job Requirements and Preferences :
Basic Qualifications :
Minimum Degree Required :
Minimum Years of Experience :
Preferred Qualifications :
Preferred Knowledge/Skills :
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).
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.
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.