Business Architect - Change Control (Remote)

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Business Architect - Change Control (Remote)

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remote type

Remote

locations

USA - Pennsylvania - West Point

USA - New Jersey - Rahway

USA - REMOTE - REMOTE

IRL - Dublin - Leopardstown (Red Oak)

IRL - Carlow - Carlow

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

R275804

Job Description
Job Description
The Digital Quality Operations team within DQ&L is tasked with simplifying the current complex QMS technology stack consisting of multiple technologies into an integrated unified quality system in order to improve the workflow, reduce high overhead costs, enhance user experience and unlock the power of data.
The Change Control Business Architect - Associate Director (AD) will ensure that change control capabilities meet the aspirations of the DQO team and provide value to the business community. The incumbent will serve as a liaison between our technology partners and key stakeholders within the business. Additionally, you will be accountable for identifying opportunities to grow and improve the IT technical landscape while simultaneously ensuring consistent performance of existing IT applications. The incumbent is expected to work collaboratively with stakeholders across the global change control landscape and to provide oversight to less senior team members, as needed.
Education:
Minimum of a B.A./B.S. in a scientific or technical discipline (such as computer science, engineering, biology, chemistry, etc.). Pharmaceutical experience preferred.

Primary Tasks/Key Responsibilities
Partner with Change Control Product Owner in the understanding, prioritization and development of strategically aligned IT solutions which deliver maximum business value.

Ensure that Change Control IT platforms are true enablers to standard process and ensure that all enhancements are consistent with this global design.

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.

Allies with other process and topics owners across the company globally to align change control, batch disposition and regulatory/CMC process in an effort to accelerate supply to patients.

Lead the end-to-end development of systems and technology blueprints and

roadmaps.

Establish strong working relationships with business and technology leaders in order to align investment planning, portfolio planning and execution with these roadmaps and

architectures.

Drive investment decisions with a mindset to optimize total cost of ownership with delivered business

value.

Promotes a common approach to the delivery of divisional business

objectives.

Required Experience and Skills:
Min. 5-10 years of Pharmaceutical Industry experience, ideally in Change Control processes. Quality/Regulatory and Digital Enablement experience strongly preferred.

Working hands-on knowledge of Change Control processes and technical applications in the pharmaceutical industry

Demonstrated 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

Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including, but not limited to executive management, business leaders, IT peers, and colleagues worldwide

Demonstrated leadership in achieving shared objectives in a matrix organization, managing cross-divisional initiatives, and cross-functional teams in an extremely dynamic environment

Demonstrated ability to envision the future and rally the organization / people towards a common goal

Comfortable challenging the status quo and possesses ability to influence and manage stakeholders

The ability to be flexible and handle multiple tasks well, under pressure.

Ability to lead and influence others outside of a direct reporting relationship.

Broad organizational awareness and knowledge of touch

points/interdependencies

#eligibleforerp
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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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:

EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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, generally Tuesday, Wednesday and either Monday or 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".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$135,500.00 - $213,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.

For Washington State Jobs, a

summary of benefits is listed here .
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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Remote

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:
Batch Processing, Biological Sciences, Business Administration, Business Architecture, Business Management, Computer Science, Corporate Management, Cost Reduction, Investment Management, Investment Strategies, IT Business Management, IT Change Management, IT Performance Management, IT Project Lifecycle, Leadership, Plan of Action and Milestones (POA&M), Portfolio Management, Product Roadmapping, Project Planning, Quality Management, Stakeholder Engagement, Strategic Thinking, Systems Development, Technology Roadmap, Workflow Solutions

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