Health Industries R&R Pharma IT Quality Manager

Specialty/Competency: Data and Analytics Technologies
Industry/Sector: Pharma and Life Sciences
Time Type: Full time
Travel Requirements: Up to 80%

A career in our Risk Management and Compliance Solutions practice, within Internal Audit services, will provide you with an opportunity to gain an understanding of an organisation’s objectives, regulatory and risk management environment, and the diverse needs of their critical stakeholders.

We focus on helping organisations look deeper and see further considering areas like culture and behaviours to help improve and embed controls.

In short, we seek to address the right risks and ultimately add value to their organisation.

Our team helps organisations anticipate risks that can threaten their strategic growth.

You’ll help organisations with improving the quality of their internal controls, enhancing reliability of information through objective testing, and increasing business alignment and cost reductions through risk and compliance efforts.

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 a purpose-led and values-driven leader at every level.

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 Manager, 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:

• Develop new skills outside of comfort zone.
• Act to resolve issues which prevent the team working effectively.
• Coach others, recognise their strengths, and encourage them to take ownership of their personal development.
• Analyse complex ideas or proposals and build a range of meaningful recommendations.
• Use multiple sources of information including broader stakeholder views to develop solutions and recommendations.
• Address sub-standard work or work that does not meet firm’s/client’s expectations.
• Use data and insights to inform conclusions and support decision-making.
• Develop a point of view on key global trends, and how they impact clients.
• Manage a variety of viewpoints to build consensus and create positive outcomes for all parties.
• Simplify complex messages, highlighting and summarising key points.
• Uphold the firm’s code of ethics and business conduct.

Job Requirements and Preferences :

Basic Qualifications :

Minimum Degree Required :

Bachelor Degree

Required Fields of Study :

Computer and Information Science, Data Processing/Analytics/Science, Statistics, Mathematics, Management Information Systems & Accounting, Engineering

Minimum Years of Experience :

5 year(s)

Preferred Qualifications :

Degree Preferred :

Bachelor in Business Administration

Bachelor of Science

Certification(s) Preferred :

CISA/CIA/CPA

Preferred Knowledge/Skills :

Demonstrates extensive knowledge and/or a proven record of success in the following areas:

• Operating in a professional services firm or pharmaceutical / life sciences / medical device / health technology company as an IT Quality / GxP compliance auditor or systems validation specialist;

• Performing on project teams and providing deliverables involving the evaluation of IT quality and GxP issues in an FDA regulated environment;

• Evaluating IT risk issues, including the use of data and technology to provide greater coverage, targeted precision and insight;

• Evaluating IT and business controls, including those relevant to GxP, IT quality and 21 CFR Part 11

• Understanding of common IT risk domains, including cybersecurity, privacy, disaster recovery, change management and IT operations

• Understanding of the software development lifecycle, including expected controls in an FDA regulated environment and associated computer systems validation;

• Understanding of Corrective and Preventive Action (CAPA) issues management in a FDA regulated environment;

• Understanding of database concepts, including building relationships between tables, grouping data, and producing cohesive analyses;

• Knowing IT architecture and IT solution development in an FDA regulated environment;

• Performing assessments to evaluate IT controls, security, SOD, and potential for optimization as well as implementation and/or configuration of ERP products;

• Having a broad understanding of the system architecture, data flow, and key financial and operational processes within a pharmaceutical, life sciences, CRO, or medical device organization.

Demonstrates extensive knowledge and/or a proven record of success in the following areas:

• Working seamlessly in a virtual environment to complete projects with team members based in various locations, domestically, and globally;

• Identifying and addressing client needs, including developing and sustaining meaningful client relationships and understanding the client’s business;

• Supervising staff, which includes creating a positive environment by monitoring workloads of the team, respecting the work-life quality of team members, providing feedback in a timely manner, performing a critical review of other’s work, informally coaching staff, and keeping leadership informed of progress and issues;

• Leading teams to generate a vision, establish direction and motivate members, create an atmosphere of trust, leverage diverse views, coach staff, and encourage improvement and innovation;

• Having project management skills in relation to data management projects, including developing project plans, budgets, and deliverables schedules;

• Possessing creative thinking, individual initiative, and flexibility in prioritizing and completing tasks;

• Researching and analyzing pertinent client, industry, and technical matters;

• Having the desire to obtain deep industry sector(s) specialization over time; and,

• Having the ability to approach clients and team members in an organized and knowledgeable manner and to deliver clear requests for information.

For positions in Colorado, visit the following link for information related to Colorado’s Equal Pay for Equal Work Act: .

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.

PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy:

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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Please note that, at this time, to be in-person at a PwC office, client location or PwC-sponsored events, you must be fully vaccinated against COVID-19.

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