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Pharmaceutical State Licensing Project Manager Jobs in Indiana

Oversee the construction and renovation of pharmaceutical manufacturing facilities, specifically ... federal, state, or local laws. This policy applies to all employment practices within our ...

Oversee the construction and renovation of pharmaceutical manufacturing facilities, specifically ... federal, state, or local laws. This policy applies to all employment practices within our ...

Senior Project Manager Pharmaceutical Industry About Salas O'Brien Founded in 1975, Salas O'Brien ... state/provincial, or local laws. Salas O'Brien will accommodate the disability-related needs of ...

CAPITAL PROJECT MANAGER

Mount Vernon, IN ยท On-site

$100K - $150K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Job Summary The Capital Project Manager - Pharmaceutical Manufacturing is responsible for leading ... Holiday Time Off (varies by site/state) * Associate Shopping Program * Health and Wellness Programs

CAPITAL PROJECT MANAGER

Mount Vernon, IN

$100K - $150K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Job Summary The Capital Project Manager - Pharmaceutical Manufacturing is responsible for leading ... Holiday Time Off (varies by site/state) * Associate Shopping Program * Health and Wellness Programs

CAPITAL PROJECT MANAGER

Mount Vernon, IN ยท On-site

$100K - $150K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Job Summary The Capital Project Manager - Pharmaceutical Manufacturing is responsible for leading ... Holiday Time Off (varies by site/state) * Associate Shopping Program * Health and Wellness Programs

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Pharmaceutical State Licensing Project Manager information

What does a pharmaceutical state licensing project manager do?

A Pharmaceutical State Licensing Project Manager oversees and coordinates the process of obtaining and maintaining state licenses required for pharmaceutical operations. This role involves managing applications, ensuring compliance with state regulations, tracking renewals, and communicating with regulatory agencies. The project manager works closely with legal, regulatory, and operational teams to ensure all licensing requirements are met efficiently. Their work helps prevent interruptions in business operations and supports the company's expansion into new markets.

What is the difference between Pharmaceutical State Licensing Project Manager vs Pharmaceutical Regulatory Specialist?

AspectPharmaceutical State Licensing Project ManagerPharmaceutical Regulatory Specialist
CredentialsTypically requires a bachelor's degree in life sciences or related field; certifications like RAC are commonSimilar credentials, often with RAC certification and relevant degrees
Work EnvironmentProject-based roles coordinating licensing across states, often within pharmaceutical companies or consulting firmsRegulatory compliance focus, working within pharmaceutical companies or regulatory agencies
Industry UsageUsed in pharmaceutical companies managing licensing projectsCommon in regulatory affairs departments
Search & Comparison IntentOften compared for licensing and project management rolesCompared for regulatory compliance and documentation expertise

The Pharmaceutical State Licensing Project Manager primarily oversees licensing projects across states, coordinating efforts to ensure compliance. The Pharmaceutical Regulatory Specialist focuses on regulatory documentation and compliance within the industry. While both roles require similar credentials and work environments, their core responsibilities differ: one manages licensing projects, the other ensures regulatory adherence.

What are the key skills and qualifications needed to thrive as a pharmaceutical state licensing project manager, and why are they important?

To thrive as a Pharmaceutical State Licensing Project Manager, you need in-depth knowledge of regulatory compliance, project management expertise, and experience in pharmaceutical licensing processes, often supported by a relevant degree and PMP certification. Familiarity with compliance management software, project tracking systems, and state-specific licensing databases is typically required. Exceptional attention to detail, organizational skills, and strong communication abilities help in coordinating between regulatory bodies and internal stakeholders. These skills ensure timely and accurate licensure, reducing compliance risks and enabling the business to operate smoothly across multiple states.

What are some common challenges faced by pharmaceutical state licensing project managers when coordinating multi-state licensing projects?

Pharmaceutical State Licensing Project Managers often encounter challenges such as navigating varying state regulations, aligning timelines for multiple applications, and ensuring documentation accuracy for each jurisdiction. Coordinating with cross-functional teams, such as legal, compliance, and operations, is essential to keep projects on track. Staying organized and proactive in communication is key, as delays in one state can impact overall project goals and company market access. Effective project managers leverage detailed tracking systems and maintain regular stakeholder updates to mitigate these challenges.

What are popular job titles related to Pharmaceutical State Licensing Project Manager jobs in Indiana?

For Pharmaceutical State Licensing Project Manager jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Pharmaceutical State Licensing Project Manager jobs in Indiana look for?

The top searched job categories for Pharmaceutical State Licensing Project Manager jobs in Indiana are:

What cities in Indiana are hiring for Pharmaceutical State Licensing Project Manager jobs?

Cities in Indiana with the most Pharmaceutical State Licensing Project Manager job openings:

Pharmaceutical Project Manager

YDU JC Air Cond & Ref Inc.- Dubai

Indianapolis, IN โ€ข On-site

$90.50 - $135/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 8 days ago


Job description

Job Summary

This role is the day-to-day project lead for validated environment and laboratory construction projects (e.g., cleanrooms, biosafety cabinets, containment suites, biocontainment labs, and related utilities) across a campus. The Project Manager reports to the Project Executive and partners with Engineering, QA/Validation, Delivery, Sponsors, and regional leadership to deliver projects within a validated-state framework, focusing on operational excellence, compliance, and both tactical and financial performance.

Responsibilities
  • Plan, execute, monitor, and close validated environment projects across multiple sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met.
  • Serve as the on-site/day-to-day project lead, coordinating owners, architects, engineers, QA/Validation, contractors, and vendors to achieve project objectives within validated-state constraints.
  • Collaborate with the Project Executive to define and maintain project scope, schedule, and budget baselines; monitor progress and report deviations.
  • Drive project schedule with a sense of urgency while not compromising quality.
  • Develop and implement validation strategies and documentation (validation plans, commissioning/qualification activities, and related records) aligned with corporate validation policy.
  • Identify, assess, and mitigate project-level risks that could impact deliverables, schedules, budgets, data integrity, or compliance; escalate as needed with proposed remedies.
  • Track and report project performance to the Project Executive, including schedule status, budget, risk, QA/validation progress, and regulatory readiness.
  • Manage and appropriately document change orders, project delays, procurement, and contract administration for assigned projects; ensure alignment with validated baselines and contract requirements.
  • Update all logs on at least a weekly basis.
  • Manage all documentation as per standards in Solution Navigator.
  • Ensure robust documentation controls that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA approvals) and support regulatory inspections.
  • Seek opportunities to improve validation workflows, data integrity practices, and delivery quality to enhance client satisfaction.
  • Maintain relationships with sponsors and stakeholders; act as a trusted advisor on validated-environment delivery and compliance at the project level.
  • Manage vendor and subcontractor performance for assigned projects, selecting qualified partners and ensuring alignment with timelines and objectives.
  • Manage project finances at the assignment level, including budgeting, forecasting, progress billings, and payables, ensuring alignment with project baselines.
  • Prepare the project team for regulatory inspections and audits through thorough documentation and traceability.
  • Foster a safe, compliant, and collaborative project environment; provide guidance to junior team members as needed.
QualificationsRequired
  • Bachelorโ€™s degree in construction, civil, mechanical, electrical engineering, construction management, business management, architecture, or a related field.
  • 5โ€“10 years of direct project management experience on large capital projects, including regulated or validated settings (typical project sizes in the $5โ€“$20M range; portfolio responsibility not required).
  • Demonstrated success delivering complex, multi-site projects in validated environments (GMP/GLP/ISO 17025) within labs, biopharma, pharmaceutical manufacturing, medical devices, healthcare, or related sectors.
  • Understanding of contract language, project accounting, and basic portfolio management as they apply to validated environments.
  • Strong executive communication skills; ability to present to senior leadership and diverse stakeholder groups; capable of influencing across functional boundaries.
  • Ability to lead and coordinate cross-functional teams (owners, architects, engineers, QA/Validation, contractors) in regulated contexts.
  • Proficiency with standard project management tools (Primavera P6, MS Project) and reporting platforms; advanced skills in MS Office with the ability to create executive-level dashboards and presentations.
  • Working knowledge of validation concepts, commissioning/qualification processes, data integrity best practices, and regulatory expectations for validated facilities.
  • Ability to establish and maintain professional relationships with key stakeholders and subcontractors in validated environments.
  • Willingness to travel and operate across multiple sites as needed.
Preferred
  • Masterโ€™s degree.
  • PMI certification (PMP) or equivalent.
  • Certifications or handsโ€‘on experience in CQV; CSV awareness.
  • Familiarity with FDA 21 CFR Part 11, EU Annex 11, and related regulatory frameworks.
  • Specific experience delivering validated environments: GMP/GLP labs, ISO 14644 cleanrooms, ISO 17025 laboratories, or similar.
  • Experience working on programs in datacenterโ€‘adjacent facilities requiring stringent validation regimes.
  • Demonstrated ability to contribute to continuous improvement programs for validation processes and data integrity across a project portfolio.
Salary & Benefits
  • Hired salary range: $90,500โ€“$135,000 (determined by education, experience, knowledge, skills, and abilities).
  • Competitive bonus plan that considers individual, group, and corporate performance.
  • Comprehensive benefits package including 401(k), medical, dental, and vision care (available day one).
  • Three weeks paid vacation per calendar year, holidays, sick time, and three PTO days per calendar year.
  • Extensive product and onโ€‘theโ€‘job/cross training opportunities.
  • Encouraging and collaborative team environment.
  • Dedication to safety through our Zero Harm policy.
  • Providing scheduling and management support.
  • JCI Employee discount programs (The Loop by Perk Spot).
Reporting Line

This position reports to the Project Executive and may supervise project coordinators or junior project team members as part of the assigned project team.

Equal Employment Opportunity Statement

Johnson Controls International plc. is an equal employment opportunity and affirmative action employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability, or any other characteristic protected by law. To view more information about your equal opportunity and nonโ€‘discrimination rights as a candidate, visit the EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please let us know.

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