Associate Director of Quality Operations

Are you an Associate Director of Quality Operations who is looking to join one of the top companies within the Radiopharmaceutical Manufacturing Industry?

Are you looking to further your career and grow?

Do you have experience in building, managing and leading Quality Operations teams?

If you answered yes to those three questions, then apply today!

Acara Solutions is seeking highly qualified candidates to work Onsite with our client in Indianapolis, IN. Interested?

Here's what you'd do:

• This role will be responsible for overseeing all Quality aspects related to GMP production of Isotopes and the client pipeline of radiopharmaceutical drug products for global clinical trial and commercial use.
• This role will partner with external and internal stakeholders driving Quality Systems at the Indianapolis site.
• The Director of Quality Operations will drive a culture of Quality and ensure GMP compliance and the successful and timely execution of day-to-day production operations supporting global distribution of isotope and drug products.
• Additional responsibilities include establishing and managing Quality Operational KPI's, supporting and driving operational improvements within the Quality organization.
• The Director of Quality Operations will support the sites transition for clinical to commercial operations and be a key Quality leader supporting operational readiness for QP, PAI and other Regulatory Authority quality audits.
• This role will drive a site culture of Quality with a patient first mindset.
• Responsible for Quality Operations oversight and day-to-day Quality management related to isotope and Radiopharmaceutical drug product manufacturing at the Indianapolis facility.
• Ensure adherence to applicable GMP regulations and company policies and procedures.
• Collaborate with other business leaders across the organization to support the development, continuous improvement and lifecycle management of GMP policies and procedures.
• Provide leadership and build an exceptional Quality Operations team.
• Champion and foster a positive and quality compliant culture with a patient safety mindset.
• Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection.
• Support compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.).
• Establish and manage Quality Operational KPI's and related metrics.
• Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility.
• Support the implementation of corporate initiatives and ensure success toward annual corporate goals and objectives.

Here's what you'll get:

• Pay rate: $185000 - $220000/Year.
• Hours: 40 hours/week
• Length: Direct Hire

Sound like a good fit?

APPLY TODAY

About Acara Solutions

Acara is a premier provider of recruiting and workforce solutions, and we help companies compete for talent. With a legacy of needs in various industries worldwide, we partner with clients, listen to them, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

• Bachelor's Degree in Science or Engineering
• Minimum 10 years of experience in building, managing and leading Quality Operations teams
• Minimum 10 years of experience in GMP operations and compliance for global clinical trial and commercial injectable or radiopharmaceutical operations.
• Minimum 10 years of US/EU regulations with regulatory agency inspection experience
• Minimum 10 years of experience in implementing and improving GMP Quality systems related to commercial manufacturing operations

• Previous experience in a commercial GMP parenteral facility, previous Radiopharma experience
• Demonstrated Quality leadership through a partnership approach with manufacturing and other Quality teams to enable high quality and compliant product distribution to patients
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
• Demonstrated excellence in written and verbal communication
• Successful candidate will have a proven history of team and personnel leadership with high levels of self-motivation, adaptability, critical thinking, analysis, and creative problem-solving.
• This is a fast-paced position within a fast-paced organization, so the ability to come in and hit the ground running is critical for success in the role.

Additional Information:

• Upon offer of employment, the individual will be subject to a background check and a drug screen.
• In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.