Senior Systems Analyst III, Clinical Manufacturing

Job Description

Job Title

Senior System Analyst III - Clinical Manufacturing Suite

Location

Waltham, MA (Hybrid Office Schedule)

Position Summary

The IT Senior System Analyst III for Clinical Manufacturing Suite will lead all technology implementation, production support, and maintenance activities within the Clinical Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding and validating new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS. Partnering closely with CMC, quality, and regulatory teams, the IT Senior System Analyst III ensures alignment with FDA and global regulatory standards while fostering continuous improvement, operational excellence, and strong collaboration across the organization. The role requires deep knowledge of pharmaceutical manufacturing processes, regulatory compliance, and IT systems integration to ensure reliable, secure, and compliant operations.

Responsibilities

Responsibilities

• Own and foster the IT-to-business relationship for Clinical Manufacturing operations, ensuring alignment of technology strategy with manufacturing leadership priorities.
• Define and manage a support and operating model for the Clinical Manufacturing Suite, maintaining application production environments to quality standards and delivering high-value implementation projects on time and on budget.
• Lead a team of internal and external, onshore and offshore IT professionals to execute implementation and support activities, ensuring SLA adherence and customer satisfaction.
• Provide oversight and expertise in Clinical Manufacturing change control, deviation management, and CAPA processes to ensure IT systems support regulatory and quality expectations; and proficient in tools like Veeva Vault, TrackWise Digital.
• Work closely with the Process Automation (PA) group to define clear roles and responsibilities between IT and PA, ensuring seamless collaboration and system ownership across both functions.
• Manage partner/vendor relationships, ensuring external service providers deliver quality and performance according to service levels and regulatory requirements.
• Develop, write, and enforce Standard Operating Procedures (SOPs) to ensure adherence to GMP guidelines across all IT-supported manufacturing processes.
• Oversee onboarding of new equipment into the Clinical Manufacturing Suite, ensuring systems are validated, compliant, and maintained according to regulatory standards.
• Maintain compliance of all existing equipment and IT systems, ensuring continuous alignment with GMP and GxP requirements.
• Lead implementation of new IT GxP systems within the suite (e.g., Data Historian, MES, LIMS), ensuring proper validation, integration, and ongoing support.
• Ensure adherence to regulatory requirements (FDA, GxP), cybersecurity standards, and departmental policies, practices, and SOPs.
• Partner with global and local IT management to align best practices across Alkermes, introducing process improvements and leveraging industry learnings.

Qualifications

Qualifications

Basic Qualifications

• Bachelor's degree in computer science, Information Systems, Engineering, or related field.
• Minimum of ten (10) years' IT experience supporting pharmaceutical manufacturing suite or with at least 5 years in technical leadership roles.
• Proven experience managing IT vendor relationships and service providers in a regulated environment.
• Demonstrated expertise in GMP and GxP compliance, including authoring, maintaining, and enforcing SOPs for IT systems supporting manufacturing operations.
• Strong background in equipment onboarding, validation, and lifecycle management to ensure systems remain compliant and audit-ready.

Preferred Qualifications

• Hands-on experience with ERP, Data Historian, Laboratory Information Management Systems (LIMS), and other GxP manufacturing support technologies.
• Deep understanding of system validation, qualification, and change control processes in pharmaceutical/biotech environments.
• Excellent verbal and written communication and presentation skills, with the ability to interact professionally with executives, managers, and subject matter experts.
• Self-starter with ability to multitask and manage simultaneous work requests across departments and cross-functional teams.
• Ability to influence, motivate, and drive alignment among project stakeholders and internal/external team members toward mutually beneficial outcomes.
• Ability to work a weekly hybrid office schedule.

Competencies

• Strategic thinker with hands-on problem-solving ability.
• Strong collaboration across IT, manufacturing, and quality functions.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Commitment to compliance, quality, and operational excellence.

The annual base salary for this position ranges from $155,000 to $170,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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