Senior Compliance Manager (digital products, platforms & services)

at  Pfizer

BASIC QUALIFICATIONS / EXPERIENCE

• Bachelor of Science degree in Information Management, Computer Science, Engineering or Technology Management preferred.
• Comprehensive knowledge on quality and compliance principles with significant experience in an enterprise compliance setting, preferably in a highly regulated industry such as banking/financial or healthcare/pharmaceutical.
• Proven compliance experience gained specifically in the IT delivery domain
• Strong general IT knowledge including an understanding of large-scale distributed systems architectures
• Strong communicative skills and the ability to simplify complex details into business operational terms in an international environment.

PREFERRED QUALIFICATIONS / EXPERIENCE

Experience as an auditor in a clinical or manufacturing domain.
Understanding of the specific areas of SaMD, HIPAA, data classification and privacy requirements strongly desired.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel may be required as part of this role. Expectations around travel will vary but you will need to be capable of travel within the region and to other regions.
Our business is a 7x24x365 endeavour. This role may on occasion require physical or virtual participation on a weekend, holiday, or after normal business hours.
Work Location Assignment: On Premise
Purpose
Breakthroughs that change patients’ lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Information & Business Tech

ROLE SUMMARY

At Pfizer we make medicines and vaccines that change patients’ lives with a global reach of over 780 million patients.
Pfizer Digital is the organization charged with winning the digital race in the pharmaceutical industry. We apply our expertise in technology, innovation and our business to support Pfizer in this mission.
The Biopharma, Patient & CDI (C4) team builds and maintains the platforms and capabilities that enable Pfizer Business Units to connect digitally with our external customers and effectively engage and collaborate across teams internally. This includes all digital (web, mobile, omni-channel, & devices) products, platforms, services and experiences in service of patients, HCPs, payors, pharmacists, or clinical sites. We build advanced cloud-based technology solutions at a global scale that positively impact Pfizer business performance.
The primary purpose of the Senior Compliance Manager is to provide compliance leadership and oversight for ensuring that C4 platforms meet their regulatory obligations when delivering services. The individual filling this role is expected to act as an SME; collaborate across stakeholders, including business owners and technical teams to guide and influence the adoption of compliance mindset. This role requires strong leadership abilities, excellent communication skills, and the passion and knowledge for enabling risk and compliance-based decision making.

ROLE RESPONSIBILITIES

Subject Matter Expertise – General

• Develops ideas and leads/co-leads complex projects across business units as a champion for regulatory compliance within the Pfizer Digital C4 organization, advocating for best practices and principles to be integrated into all aspects of the software development process.
• Applies comprehensive understanding of the relevant regulatory requirements to the delivery of technical solutions and services to a global audience including both external and internal customers. The candidate will be able to show subject matter expertise that includes specific compliance areas such as SaMD (Software as Medical Device) and HIPAA.
• Defines and drives audit processes and the effective response to findings including the agreement of CAPAs (Corrective Action, Preventative Action) where required.
• Develops, conducts, and/or supports organization wide training sessions, workshops, and Knowledge sharing sessions to enhance the skills and capabilities of software development teams on compliance practices.

Strategic Leadership & Delivery

• Responsible for the strategy to deliver compliant services and solutions including working directly with the technical lead for qualified infrastructure to build in compliance at the foundational level.
• Maintains an awareness of compliance issues, changes, developments externally that may inform strategy or drive required change.

Cross- Team Collaboration

• Fosters cross team and organizational relationships with an ability to lead in or act as an contributor in very large scale efforts.
• Establishes a close relationship with compliance partners across Pfizer to both provide the C4 context and to be aware of the broader Pfizer compliance landscape.
• Provides input to senior management decisions that may have an impact on business direction within the Business Unit

Coaching and Mentorship

• Engages with technical and non-technical teams to provide practical compliance guidance allowing successful outcomes to be delivered at pace but without risk.
• Acts as a promoter for a compliance mindset across the organization to help the organization maintain compliance and build solutions in a compliance aware way.