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Post Market Quality Product Owner

Location: Remote

Description:

We are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Quality is a competitive advantage. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient's right and every employee's responsibility.

As a Global Quality & Regulatory Post Market Quality Product Owner, you are accountable for the global alignment between the Quality Management System (QMS) framework and the Post Market Quality (PMQ) tool landscape. Ensuring that the PMQ tools support the modular framework and are compliant with applicable and regional regulatory requirements. Influencing Senior Leaders such as General Managers and Regional Managers' acceptance and adoption of the global PMQ tools.

You are a strong matrix leader who is ready to enthusiastically partner with our sites, Affiliates, and IT to ensure that our tools meet requirements and our right to operate and help us create value.

You will be responsible to

Drive business results and customer value

1. Responsible for the health of Post Market Quality System Applications in terms

of quality and operational effectiveness from a functional and technical

perspective. Provide SAFe Agile execution of the enterprise-wide PMQ tools.

2. Understands business needs and priorities, uses multiple sources of information

including broader stakeholder views to develop solutions and recommendations

by bringing an end-to-end process approach. This requires ongoing, proactive

interaction with cross-functional users while providing consistent communication

with various functions. There is a key focus on managing the relationship with the

business at both a strategic and portfolio level to ensure the IT organization has

early insight into changing business directions in order to inform and shape IT

demand.

3. Acts as a product owner and works closely with IT, PMQ SMEs, and other

applicable stakeholders in the planning and design of application

implementations, changes and coordinating on delivery and deployment

processes. As an evangelist, this position stays abreast of functional and

development tools, trends, and practices that should be considered for future

initiatives.

4. Develops deep business and application domain knowledge for the PMQ business

portfolio to aid in critically evaluating the balance of both business needs and user

requests.

5. Globally influence the acceptance and realization of the PMQ tools across all

Roche Diagnostics Sites & Affiliates, ensuring the QMS tool delivers on the

objectives as an enabler to the Diagnostics 10 year Strategy.

6. Accountable to ensure that our tools meet Health Authority regulations, Notified

Body requirements, Company standards and expectations throughout the global

organization including operations, development, and affiliate sites.

7. Provide matrix leadership and guidance to staff executing Quality Management

System functions and adoption of the PMQ tools.

8. Assume the role of Source Data Product Owner; ensuring transactional data is

FAIR (findable, accessible, interoperable, reusable) and consumable within

Roche's global data warehouse (snowflake).

9. Curating Post Market Quality data and participating in Data Squads to ensure

PMQ data is easily interpreted and consumable.

10. Analyzes business and user needs, establishes clear business value objectives,

documents requirements, and revise existing system logic or business process

difficulties to select, build or modify large, complex or mission critical

information systems to achieve business value

11. Adds value to the delivery team by working with the business and product owner to create clarity around business objectives through the development of and refinement of user stories

Empower and enable the Network

1. Lead, coach, and guide the organization.

2. Be the champion and advocate for Engrained Quality globally.

3. Build a culture of continuous improvement and model matrix leadership

principles.

Enable the organization's New Ways of Working

1. Act as role model for Agile Matrix Leadership behaviors, as well as for our

culture, mindset & behaviors

2. Model behaviors to support the organization's transformation to new, more Agile Ways of Working.

3. Everything you do should contribute directly to the achievement of our Roche Ten

Year ambitions, including:

- Double patient access to novel, high-medical-value diagnostics solutions

- Build the leading, profitable insights business

- Improve patients' lives via 'One Approach' to ecosystem in every

country

High degree of subject matter expertise:

- At least eight (8) years of IT experience within Quality and Regulatory focusing on Post

Market Quality or equivalent experience and demonstrated knowledge of PMQ

processes.

- Salesfore, Trackwise (Honeywell), Smarteeva applications

- Agile/ Waterfall methodologies / Software Development Life Cycle (SDLC) process

experience

- At least ten (10) years in the Medical Device/Pharma/Biopharmaceutical industry with 5

years working in Quality, Compliance, Regulatory and/or Validation, preferred or

equivalent experience.

- Bachelor's / Master degree in Life Science, Pharmacy or related subject. Advanced

degree is considered an advantage.

- Excellent knowledge of the European, US, China and International cGMP regulations

and demonstrated ability to adequately interpret and implement quality standards.

#DICE