Pharma Life Sciences - Quality Management Systems Manager

Pwc San Francisco , CA 94118

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.


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.

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

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
Life Sciences Technology Consulting Manager

Accenture Contractor Jobs

Posted 1 week ago

VIEW JOBS 5/21/2020 12:00:00 AM 2020-08-19T00:00 We Are 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 companythat 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 way the world works and lives. You Are An R&D tech consultant beyond compare. You've got an in-depth understanding of the pharmaceutical industry and you know how business, technology and operations intersect. So, you use your analytical know how and skills to solve problems creatively, and make sure clients have R&D technology and processes that help get products to patients faster. Your soft skills complement your technology know-how, which means you can always get your point across, whether you're talking with a senior client or a junior team member. All in all, you're the person others seek out when they run into challenges. The Work (Role Responsibility) * Work on proprietary technology assets to deliver best-in-class R&D services to our clients; * Evaluate the technology currently supporting clients' product development, patient services and regulatory compliance strategies; * Lead teams developing and deploying technologies used to discover and develop therapies such as compounds, biologics, vaccines, medical technology, etc.; * Organize and rationalize tech systems after mergers; * Design and deploy change management projects that set up clients for long-term success; * Build relationships with client stakeholders in the health, biopharmaceutical and medical device industries that help Accenture become a trusted partner; * Support business development efforts; * Manage and coach junior team members; * Support business development efforts and expand our thought leadership position using your expertise in life sciences to apply new technology such as cloud computing, application, platforms, etc. Typically, we work at client sites and aim for our people to work local. Depending on your location and specific project responsibilities, this position may require travel 3 to 4 days per week. Accenture Contractor Jobs San Francisco CA

Pharma Life Sciences - Quality Management Systems Manager