Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP/GLP Quality Assurance activities, ensuring meticulous adherence to standards that drive our growth objectives forward. Beyond external engagements, you'll be a key collaborator, bridging departments to fortify our operational integrity. Your focus on developing our QA infrastructure will be instrumental in realizing our strategic initiatives. If you're ready to bring your analytical prowess to the table, join us and report directly to the head of RA/QA as we navigate the complexities of quality assurance with precision and purpose.

Requirements

What will you be doing?

• Development, implementation, maintenance of quality assurance infrastructure & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.

• Implementing process improvements required to ensure GxP compliance in early clinical development environment with strategic view toward growth as products advance to late-stage development and commercialization.

• Coordinating internal and external quality audits and preparing of audit reports, corrective action plans and follow up updates.

• Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective.

• Ensure supplier quality objectives are met.

• Provide technical leadership for Quality Assurance activities and deliverables in support of product development.

• Collaborate with management and all functional groups to drive a culture of quality.

• Implement, monitor, and promote best practices of Quality Management systems to ensure compliance with relevant FDA, EU and global regulations/directives/requirements.

• Identify, resolve, or escalate product, process, or customer quality-related issues that pose risk with respect to patient, customers, or regulatory compliance.

Traits we believe make a strong candidate:

• BS in life sciences, physical sciences or relevant discipline +8 yrs pharma/biotech experience in Quality Assurance with a preference given for advanced degree / relevant professional certification (e.g. CQA, CQE)

• Analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.

• Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities

• Direct experience with FDA Quality System Regulations and regulatory requirements and implementation.

• Outstanding communication skills, both verbal and written, and the ability to interface effectively across key functional areas.

• Strong conceptual, analytical, and problem-solving abilities.

• Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines.

• Proven experience in leading change management initiatives through periods of rapid expansion.

• Embody a culture of quality improvement and progress; promote knowledge sharing.

• Familiarity with global regulatory and compliance requirements for clinical development and relevant quality standards, including but not limited to: US CFR, EU CTD, and ICH GCP

• Familiarity with electronic document management systems and computer system validation

• Role is office based and will travel based on business needs, typically 10-30%, but flexing higher when needed.

Benefits

• Health Care Plan (Medical, Dental & Vision)

• Retirement Plan (401k, IRA)

• Life Insurance (Basic, Voluntary & AD&D)

• Paid Time Off (Vacation, Sick & Public Holidays)

• Family Leave (Maternity, Paternity)

• Short Term & Long Term Disability

• Training & Development

• Free Food & Snacks

• Wellness Resources

• Stock Option Plan

At Frontier we strive to build a diverse and equitable workplace. The salary range for this role is $140,000 - $180,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.

This compensation and benefits information is based on Frontier’s knowledge as of the date of publication, and may be modified in the future.