Job Description
Join our team at the forefront of digital transformation in the biopharmaceutical industry. As a Product Owner - Change Control, you will play a pivotal role in simplifying our Quality Management System (QMS) technology stack and enhancing user experience. This is an exciting opportunity to leverage your expertise in digital technologies and quality management to make a significant impact on our business operations and ultimately, patient lives.
Key Responsibilities
Develop value maps, product roadmaps, and lead roadmap discussions with various stakeholders, communicating the results to the technical teams.
Understand, prioritize, and develop strategically aligned IT solutions which deliver maximum business value.
Ensure that Change Control Digital Solutions are true enablers to standard processes and ensure that all enhancements are consistent with this global design.
Define requirements, translate them between the development and business-facing teams, and document them for GxP systems.
Drive continuous product discovery to understand user needs and translate that to solutions and product backlog.
Create, maintain, and continuously prioritize the product backlog to maximize value delivery and long-term sustainability.
Work with Product Managers to develop and convey accurate and realistic project plans, resource estimates, and timelines in alignment with prioritized business requirements.
Ensure all IT systems are designed, built, and operated in an SDLC compliant manner and promote the effective use of IT standards and tools.
Lead the end-to-end development of systems and technology blueprints and product roadmaps.
Establish strong working relationships with business and technology leaders to align investment planning, portfolio planning, and execution with these roadmaps and architectures.
Monitor and optimize the product’s total cost of ownership (TCO).
Develop and regularly calibrate metrics of the Digital Products.
Drive release and support planning and execution (go to market).
Connect delivery squads with the customers and facilitate direct communication.
Education:
Bachelor’s degree in computer science, engineering, biology, chemistry, or scientific field.
Required Experience and Skills:
10 years of Pharmaceutical Industry experience. Quality/Regulatory and Digital Enablement experience strongly preferred.
Experience designing, simplifying, and digitizing pharmaceutical industry quality management systems processes.
Demonstrated ability to lead cross-functional teams, manage complex projects, and drive organizational change.
Proven experience as a Technical Product Owner, able to define and prioritize product backlogs and collaborate effectively with development teams.
Excellent verbal and written communication skills, with the ability to present complex concepts to senior leadership.
Proficiency with Veeva Vault, Trackwise, SAP, Dataiku, and other relevant software for quality management and change control.
Preferred Experience and Skills:
Experience with data science, AI implementation, data engineering, or other adjacent technical fields.
Ability to partner with business stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs.
Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity at the center.
Strong analytical and problem-solving skills, with the ability to make data-driven decisions and solve complex technical problems.
Ability to effectively collaborate and communicate with a variety of audiences and stakeholders, including executive management, business leaders, IT peers, and colleagues worldwide.
Extensive experience with Agile methodologies and project management tools like JIRA and Confluence.
Experience with Veeva QMS, Change Control or adjacent business processes, and SAP ERP (a plus).
Experience in implementation of large global cloud platforms in the pharma and life sciences industry.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers’ Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$169,700.00 - $267,200.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs
Preferred Skills:
Job Posting End Date:
02/10/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
