Sr Manager Quality, Contamination Control Strategy Lead
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington Indiana US and Halle/Westfalen Germany we offer a wide range of delivery systems including pre-filled syringes liquid/lyophilized vials diluents for reconstitution powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules cytotoxics highly potent compounds diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing we offer many support services including formulation and development lyophilization optimization global regulatory support and secondary packaging. Our teams are driven to help clients scale innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra Because we:
Make it HAPPEN We bring a growth mindset to every opportunity developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER We work as one respecting each voice and tapping into our unique strengths across teamsso we can solve problems in new ways.
Make it RIGHT We hold ourselves to a high standard of excellencefulfilling our commitments to the customer their patients and our team members.
Make it COUNT We take pride in our day-to-day work knowing the impact we make taking on challenges big and small to improve patient health.
The role:
The Sr Manager Quality Contamination Control Strategy Lead is responsible for establishing maintaining and continuously improving the contamination control strategy at a sterile injectable manufacturing facility. He/she needs to drive compliance with regulatory requirements (FDA EMA PIC/S Annex 1) and contamination control initiatives microbiological oversight collaboration and aseptic assurance across the manufacturing site. This role serves as the SME (subject matter expert) for aseptic practices maintenance of aseptic observation program data metrics and the overall contamination control strategy (CCS).
The Sr Quality Manager is expected to contribute to an environment where teamwork and productivity are encouraged and safety identity strength purity and quality (SISPQ) are reflected in the finished addition the Sr Quality Manager is expected to partner with QALO and operations leadership training leadership and the Contamination Control Strategy Team.
The responsibilities:
- Owns the aseptic observer program including oversight of aseptic practices cleanroom behavior and gowning:
- Responsible for design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
- Organize collected data from Aseptic Observer Program analyze trends lead cross functional review meetings and make necessary improvements with operations leadership based on observations
The qualifications:
- Education: Bachelors degree in Microbiology (preferred) Biology Pharmacy or related science.
- Masters degree or higher in Microbiology or Pharmaceutical Sciences is preferred
- Minimum of 8 years of direct experience in sterile pharmaceutical manufacturing or QC microbiology / QA roles including at least 5 years in SME capacity related to contamination control.
- Demonstrated leadership or cross-functional team experience in aseptic processing environments (e.g. controlled areas (specifically A/B isolators OPEN and CLOSED RABS systems).
- Proven track record of successful regulatory inspection participation (FDA EMA or equivalent) as SME for contamination control topics
- Strong knowledge of EU GMP Annex 1 21 CFR parts 210/211 USP<71> <85> <1116> <797> <1207> and current industry best practices
- Understanding of aseptic processing data interpretation aseptic filling processes and equipment strategies CCS design and Quality Risk management (ICH Q9).
- Strong communication skills as the role is expected to interface with clients regulatory agencies and site leadership and being able to make decisions.
- Strong technical writing skills for strategy documents assessments and investigations.
- Strong attention-to-detail decision-making capability and problem-solving in complex technical environments
- Ability to train mentor and coach staff in aseptic technique and contamination control.
Working conditions:
- Role requires frequent presence in Grade A/B aseptic environments; gowning certification is required.
- May require occasional off-shift off-hours support during media fills regulatory inspections or critical interventions
In return youll be eligible for1:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life 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
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
1 Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy: Experience:
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About Company
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