Job description

Your Role:

The Indianapolis manufacturing facility is a contract manufacturing site that specializes in manufacturing lipid nanoparticle, liposome, and pegylation formulations. The Head of Quality will be responsible for all aspects of the quality organization within this CDMO business. As part of a dynamic Contract Manufacturing Organization, you will work with internal and external stakeholders to manage complex timelines, meet customer deliverables, and develop a best-in-class quality organization.  You will liaise closely with external customers. You will oversee the teams for the Quality Assurance and the Quality Control departments.

As Head of Quality, you will manage and develop the quality group to further mature a site culture of compliance excellence and continuous improvement. You will represent the company in interactions with customers and governmental agencies to ensure regulatory requirements and customer expectations are met. Also, provide mentoring and development opportunities for both direct and indirect staff to ensure adequate number of properly trained individuals are available to scale up with business growth. There is a high degree of customer interaction supporting technology transfer and validation of customer-owned processes as part of a CDMO operation.

Additional responsibilities:

• In partnership with the Site Head you will develop, implement, and maintain the Quality Management System (QMS) to be compliant with applicable regulations as defined for Active Pharmaceutical Ingredients, Excipients, and GMP raw materials (21CFR 210 & 211, ICH Q7, EU EudraLex) and other necessary standard and regulations required.
• Responsible for final release of all products, ensuring quality and regulatory requirements are met.
• Ensure inspection readiness of the site to confirm regulatory compliance and continued plant operations.
• Manage inspections by local and global regulatory agencies, and acts as the primary contact for regulatory issues for the facility and participate in responses and any follow up action.
• In partnership with the site leadership team, develop and implement effective contamination control strategy is in place to meet the manufacturing and product requirements, and develops procedures for the required levels of aseptic processing as applicable.
• In collaboration with internal business partners, liaise with clients to ensure that the appropriate quality requirement is applied during technology transfer from development to commercial manufacturing.
• Maintain knowledge of cGMP compliance as it relates to API manufacturing and testing, and implement the necessary systems, procedures, documentation, and training to maintain cGMP compliance.
• Sponsor process improvement initiatives within the Quality Department and institutes programs and projects to improve site’s level of compliance to remain in line with changing regulatory demands.
• Collaborate with divisional quality management to ensure site compliance to Corporate Quality policies and supports the overall Corporate Quality Systems harmonization process.
• Manage department budget in line with expectations, as well as pursuing cost reductions in all possible areas.
• Final site decision point for all quality related issues.

Who You Are:

Minimum Qualifications:

• Bachelor Degree in a scientific discipline required; Advanced degree strongly preferred.
• 10+ years experience in a pharmaceutical quality or manufacturing environment or related field.
• 5+ years of management experience in a cGMP regulated industry.
• Extensive knowledge with cGMP requirements for APIs, and Pharmaceuticals and governmental regulations and guidelines, and the ability to interpret and apply them.
• Experience in managing inspections by regulatory agencies (FDA, EMEA, etc.).
• Understanding of validation process associated with GMP product development and manufacture through the pharmaceutical life cycle.
• Experience interacting closely with external customers.

Preferred Qualifications:

• Experience in GMP contact manufacturing with demonstrated experience with customer interaction is preferred.
• Understanding of analytical chemistry and laboratory procedures.
• Understanding of microbiology and contamination control.
• Demonstrated communication and leadership skills with proven ability to manage large teams of Quality professionals.
• Strong technical writing and interpretation skills related to investigations and Regulatory Filings.
• Thorough knowledge of Project Management and Process Improvement skills.
• Six Sigma/Lean Manufacturing qualification desirable.

Job Type: Full-time

Pay: From $190,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Relocation assistance
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay
• Signing bonus

Ability to commute/relocate:

• Indianapolis, IN 46268: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:

• Manufacturing: 10 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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