Pharma Life Sciences - Quality Management Systems Sr. Associate

Pwc Miami , FL 33196

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Management Systems Business Analyst

Accenture Contractor Jobs

Posted 2 weeks ago

VIEW JOBS 5/21/2020 12:00:00 AM 2020-08-19T00:00 Accenture Consulting: Your Unique Place in our Global Collective Being part of Accenture Consulting means becoming an expert at making the New happen Now. To us, the New is all about the wise pivot that turns constant disruption to continuous reinvention. We are an innovation led-company that works at the heart of our clients' organizations so that no matter how complex the business challenge, we face the future with confidence. If you love solving challenges and not just studying them, then Accenture Consulting is the right place for you. Join us to develop your ideas into provocative points of view and transformative insights that help shape industries. You'll work with an amazing and diverse mix of world-class experts with access to one of the most robust portfolios of capabilities and ecosystem relationships in the industry. Together, you'll do so much more than consult. Coming here means future-proofing your career and going as far as your ambition takes you. Becoming a tech-savvy, well-rounded, multi-disciplined and market-relevant advisor doesn't happen by chance. We invest in training and development in a big way, so you can build your future along with ours, creating an impactful career unique to you. Ultimately, we believe we is greater than me and that diverse perspectives lead to the best solutions. Joining Accenture Consulting means you will learn, innovate and lead, and together we will improve the way the world works and lives. As an Accenture Scientific Informatics Services (ASIS) consultant you will be exposed to the technologies and processes that many leading US companies and government agencies utilize. We offer a generous compensation package consisting of salary, bonuses and benefits. Job Description Understand and Identify business processes and improvements for QMS domain in a GMP environment. In order of importance, prior QMS related experience should include CAPA, Change Control, Investigation Management, Document Management, and Training Identify opportunities for improvement and efficiencies gained by successfully adopting new QMS solutions i.e. Veeva, Master Control, Trackwise, ComplianceWire, SumTotal. Under minimal supervision from a more senior business analyst or project manager * With business stakeholders, implement business process improvements * Create use cases * Create high quality user and functional requirements * Analyze requirements to determine priority and business value * Facilitate meetings, document meeting notes and distribute meeting notes to invitees * Facilitate interviews, site visits and workshop sessions with business users one-to-one and in groups. * Create required regulatory and SDLC documentation * Collect information regarding and monitor progress of business analysis activities * Create ASIS and to-be process maps and narratives * Create requirements traceability matrices * Provide estimates for workstream activities, including dependencies, to the Project Manager * Identify, manage and resolve risks and issues related to the workstream * Provide Project Manager with status updates, activity progress and schedule updates Maintain excellent client relationships * Review and estimate change requests * Create and maintain SDLC documentation * Contribute to all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training Work with project teams to ensure compliance with regulatory requirements such as FDA, CAPA, CLIA, GxP,HL7 as well as internal policies and processes * Create and deliver training materials to end users * Collect and monitor progress on project activities from resources * Determine and document overall workstream approach plan and estimate activities within the workstream * Provide leadership for all resources within a specific workstream including client, vendor, consultants and associates * Perform stakeholder identification and analysis Determine if defects are valid and disposition them Accenture Contractor Jobs Miami FL

Pharma Life Sciences - Quality Management Systems Sr. Associate

Pwc