Senior Quality Manager I, Auditing

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 teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling 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 Quality Manager, Auditing, is a member of the Quality Leadership Team reporting to Quality Compliance leadership. He or she provides leadership and direction for regulatory, internal, and client quality audits, compliance with new regulations and guidance documents.

The responsibilities:

• Monitors implementation and compliance of the requirements established by the Plant’s Quality System.
• Maintains site inspection readiness programs, including inspection preparation activities, mock inspections, inspection room coordination, and inspection readiness training.
• Manages the Regulatory Inspection process. Hosts regulatory agencies during inspections, provides leadership to team members, and manages inspections from initiation through closure.
• Oversees the Internal Audit Program: Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines.
• Ensures that audit schedules are produced and communicated in a timely fashion. Supports and leads for-cause, audits, as needed.
• Plans and develops audit assessment strategies and logistics. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions.
• Evaluates and approves audit and inspection responses, ensures corrective and preventive actions are appropriately developed, implemented, and closed in accordance with site procedures, and identifies recurring compliance issues for escalation.
• Provides oversight and support for facility Client audits. Approves client audit response reports and ensures commitments made are tracked to completion.
• Executes quality system questionnaires to support new and existing client relationships.
• Collaborates with Regulatory Affairs team to complete submission and inspection related client application petition requests.
• Participates in the development of annual cGMP/GDP training as needed.
• Provides 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. Assists 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.
• Leads teams in continuous improvement project activities.

The requirements:

• Bachelor's degree required, preference in a Life Science field.
• Minimum 7 years experience in Quality - Auditing or equivalent pharmaceutical industry experience.
• Minimum 3 years experience leading teams, projects, quality systems, or compliance programs within a GMP-regulated environment.
• Previous auditing experience in an FDA and EU-regulated aseptic pharmaceutical facility is required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva Vault eQMS, Trackwise, D365, DocuSign, etc.)
• ASQ and/or RAB auditor accreditation is desired.
• Extensive working knowledge of applicable quality and regulatory standards and regulations. Expertise in global GMP regulations.
• Excellent communication skills – both written and oral.
• Work effectively independently and in team environment.
• Must demonstrate sound judgment, problem-solving, and analytical skills to enable assessment of risk. Experience with risk management and root cause analysis preferred.
• Strong courage of conviction, conflict resolution, interpersonal and influencing skills.
• Ability to build relationships across functional boundaries at multiple levels internally/externally.
• Ability to demonstrate strong organizational and project management skills.
• Resourceful, self-reliant, self-motivated and confident.

Physical / Safety Requirements

• Must be able to qualify to gown into classified areas (Grade C or higher) and navigate mechanical spaces within the facility.
• 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 long periods of time.

In return, you’ll be eligible for [1] :

• 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.

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