Simtra BioPharma Solutions · 1 month ago
Sr. Manager, Quality Operations
Bloomington, Indiana, United States
Full-time
Onsite
Senior Level
7+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization specializing in sterile injectable products. The Sr. Manager, Quality Assurance Line Operation will oversee quality operations, ensuring compliance with regulatory standards and leading a team to maintain product quality and safety.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Plan, organize, direct, and evaluate applicable activities to ensure the safety and quality of manufactured products
Demonstrates outstanding customer service to both internal and external clients
Develops and delivers solutions on time that meet customer expectations
Demonstrates excellent leadership skills thru guidance, support, direction and through interactions with all personnel during daily operations. Must be a regular presence on the manufacturing floor
Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans
Creates/Develops a strong team by setting clear direction and empowering members to obtain results that support strategic objectives
Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions as necessary to meet plant and department goals/objectives
Develops department annual budget and ensures spending within expected quarterly forecasts
Ensure Quality review of batch records in order to achieve internal targets and contractual commitments for batch release
Responsible for ensuring compliance to plant procedures, corporate quality policies, Federal and European regulations and guidance
Ensures training compliance for QA Line Operations
Responsible for establishing & trending quality metrics, taking action as required to meet regulatory requirements and customer expectations
Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
Represent Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs
Review and Approve Non-Conformance Reports for deviations and or non-compliance issues that occur during production activities and ensures thorough investigation, root cause analysis, and corrective and preventative action
Qualification
Required
Bachelor's degree required, preference in a Life Science field
Minimum 7 years experience pharmaceutical industry experience
Minimum 3 years in a management role
Computer proficiency in Microsoft Office Suite and the ability to use ERP, E Quality & enterprise software
Must be able to qualify for entry into Class A/B aseptic facilities
Must wear appropriate personal protective equipment as applicable
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position requires sitting for long hours, but may involve walking or standing for periods of time
Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Workout Facility
Cafeteria
Credit Union
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase