Stark Pharma
QA Regulatory Compliance Specialist
Location:
Indianapolis, IN (Onsite)
Contract Duration:
12+ Months
Experience:
8+ years
Role Overview:
The GMP Quality Compliance Lead will support and maintain Quality Systems within a GMP‑regulated biopharmaceutical manufacturing environment. This role focuses on ensuring inspection readiness, driving compliance initiatives, supporting regulatory activities, and strengthening quality governance across operations.
Key Responsibilities
Support and implement Quality Systems in alignment with cGMP, FDA, ICH, and EU regulatory requirements
Lead and support Quality Management Review activities, including metrics tracking and reporting
Ensure ongoing inspection readiness and participate in regulatory inspections and audits
Manage QA compliance programs, including internal audits and self‑inspections
Review, approve, and support investigations, deviations, CAPAs, and change controls
Ensure data integrity compliance in accordance with ALCOA+ principles
Author, review, and approve SOPs, policies, and quality documentation
Provide QA guidance to cross‑functional teams on compliance‑related matters
Support regulatory submissions, responses, and commitments as needed
Identify compliance gaps and drive continuous quality improvement initiatives
Required Qualifications
Bachelor's degree in Life Sciences or a related discipline
8+ years of experience in a GMP biopharmaceutical manufacturing environment
Minimum 2+ years ofstatus hands‑on Quality Assurance experience
Strong working knowledge of cGMP, FDA, ICH, and EU regulations
Proven experience with QA compliance programs and inspection readiness
Solid understanding of data integrity principles, including ALCOA+
Experience conducting or supporting self‑inspections and internal audits
Strong SOP authoring, reviewing, and document control experience
Ability to work onsite and collaborate effectively with cross‑functional teams
Preferred Qualifications
Experience supporting radiopharmaceutical or sterile manufacturing operations
Prior involvement in regulatory agency inspections
Strong communication, documentation, and problem‑solving skills
Seniority Level Mid‑Senior[:] level
Employment Type Contract
Job Function Quality Assurance
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Indianapolis, IN (Onsite)
Contract Duration:
12+ Months
Experience:
8+ years
Role Overview:
The GMP Quality Compliance Lead will support and maintain Quality Systems within a GMP‑regulated biopharmaceutical manufacturing environment. This role focuses on ensuring inspection readiness, driving compliance initiatives, supporting regulatory activities, and strengthening quality governance across operations.
Key Responsibilities
Support and implement Quality Systems in alignment with cGMP, FDA, ICH, and EU regulatory requirements
Lead and support Quality Management Review activities, including metrics tracking and reporting
Ensure ongoing inspection readiness and participate in regulatory inspections and audits
Manage QA compliance programs, including internal audits and self‑inspections
Review, approve, and support investigations, deviations, CAPAs, and change controls
Ensure data integrity compliance in accordance with ALCOA+ principles
Author, review, and approve SOPs, policies, and quality documentation
Provide QA guidance to cross‑functional teams on compliance‑related matters
Support regulatory submissions, responses, and commitments as needed
Identify compliance gaps and drive continuous quality improvement initiatives
Required Qualifications
Bachelor's degree in Life Sciences or a related discipline
8+ years of experience in a GMP biopharmaceutical manufacturing environment
Minimum 2+ years ofstatus hands‑on Quality Assurance experience
Strong working knowledge of cGMP, FDA, ICH, and EU regulations
Proven experience with QA compliance programs and inspection readiness
Solid understanding of data integrity principles, including ALCOA+
Experience conducting or supporting self‑inspections and internal audits
Strong SOP authoring, reviewing, and document control experience
Ability to work onsite and collaborate effectively with cross‑functional teams
Preferred Qualifications
Experience supporting radiopharmaceutical or sterile manufacturing operations
Prior involvement in regulatory agency inspections
Strong communication, documentation, and problem‑solving skills
Seniority Level Mid‑Senior[:] level
Employment Type Contract
Job Function Quality Assurance
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