Associate Director of QA
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
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 Associate Director of Quality Assurance is a member of the Quality Assurance Leadership Team reporting directly to the Quality Director. He or she provides leadership and direction for Filling Quality Line Operations and Finishing Quality Line Operations. The Associate Director provides decision making and oversight to ensure compliance to all standard operating procedures for areas of responsibility. He or she must fully support and drive quality operations communicate effectively with production team members multiple levels of management and other customer support departments. The Associate Director creates an environment where teamwork productivity safety identity strength purity and quality (SISPQ) are reflected in the finished product.
The responsibilities:
- Provide guidance support direction and leadership through positive interactions with all personnel during daily operations.
- 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.
- Develops department annual budget and ensures spending within expected quarterly forecasts.
- Plan organize direct and evaluate applicable activities to ensure the safety and reliability of manufactured products.
- Responsible for ensuring compliance to plant procedures corporate quality policies Federal and European regulations and guidance.
- Facilitate an environment of teamwork and communication between Quality Assurance Production and other support functions as necessary to meet plant and department goals/objectives.
- Ensures training compliance for QA team.
- Supports QA oversight of Aseptic Filling operations Inspection Labeling and Packaging operations and Warehouse operations including finished product reserve sample inspection finished product sampling and shipping.
- Participates in escalated client issue resolution (conference calls client visits audits).
- Responsible for tracking and trending Quality data for review and reporting.
- Lead teams in continuous improvement project activities.
- 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 deviations and or non-compliance issues that occur during production activities and ensures thorough investigation root cause analysis and corrective and preventative action.
- Serve as designee for some reviews and approvals performed by the Quality Director including Quality Review Board endorsements.
- Responsible for setting strategic direction of department including coordination of coverage across team to support filling and packaging operations 24/7.
The requirements:
- Bachelors degree required preference in a Life Science field; advanced degree preferred.
- 12 years of pharmaceutical manufacturing experience required. Preference in quality operations manufacturing or technical services
- Minimum 10 years experience in a management role.
- In-depth knowledge of FDA Annex One requirements and supporting audits
- Experience with international regulatory bodies preferred
- Computer proficiency in Microsoft Word Excel and Outlook and the ability to use enterprise software (examples include: JDE BPLM Pilgrim Trackwise etc.)
Physical / Safety Requirements:
- 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.
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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