Quality Assurance Manager - CMC and 3rd Party Support

Perspective Therapeutics; United States; On-site; USD 135,000 - 170,000; Full time

Job summary

A leading biotechnology company is seeking a Quality Assurance Manager - CMC and 3rd Party Support. The successful candidate will ensure compliance with GMP standards and manage quality systems essential for product lifecycle. This role requires strong project management skills and extensive experience in the pharmaceutical industry, contributing directly to successful product outcomes.

Benefits

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Qualifications

• 7+ years’ experience in Pharmaceutical Industry in a similar function.
• Experience with regulatory agency inspections.
• Broad knowledge of risk-based quality systems.

Responsibilities

• Provide QA support for clinical and pre-commercial product disposition.
• Manage quality aspects of clinical projects from raw materials to release.
• Perform audits and establish Quality Agreements with vendors.

Skills

GMP understanding

Quality Management System

Project Management

Communication

Education

Bachelor’s degree in chemistry or related field

Job description

Quality Assurance Manager - CMC and 3rd Party Support

Join to apply for the Quality Assurance Manager - CMC and 3rd Party Support role at Perspective Therapeutics

Quality Assurance Manager - CMC and 3rd Party Support

Join to apply for the Quality Assurance Manager - CMC and 3rd Party Support role at Perspective Therapeutics

Direct message the job poster from Perspective Therapeutics

Perspective Therapeutics is seeking a highly motivated and detail-oriented Quality Assurance CMC & 3rd Party Support Manager to join our team. This individual will play a critical role supporting the oversight and management of Chemistry, Manufacturing, and Controls (CMC) activities and related 3rd parties, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements throughout the product lifecycle. The ideal candidate will contribute to the development, implementation, and maintenance of robust Quality Management System (QMS) elements, facilitating seamless coordination between Research and Development, Manufacturing, Regulatory Affairs teams and 3rd party partners. As a key player in our quality assurance efforts, the Manager will help uphold the highest standards of product quality and safety, directly impacting the success of our clinical and commercial endeavors.

Essential Functions

• Provide QA support for clinical and pre-commercial product disposition and distribution.
• Responsible for review and approval of master batch records, methods validation protocols and reports, test methods, specifications, etc. for clinical late stage clinical and commercial peptide products.
• Manage the quality aspects of clinical project from raw materials to manufacturing to packaging, distribution and release/stability.
• Focus on establishing, implementing, and maintaining quality operations systems that support manufacturing activities.
• Perform ongoing review of batch records as part of product release, oversight of deviations and CAPAs, and ensuring appropriate communication of issues, development and plans.
• Establish quality-to-quality relationships with CDMOs and related 3rd parties.
• Support application of clinical phase appropriate quality requirements.
• Responsible for assisting in any Health Authority inspection preparation, acting as SME when needed and in providing or reviewing responses to findings from such inspections.
• Responsible for release or rejection of GMP materials and coordinate with QA staff to manage the timeline and ensure on time delivery of approved materials.
• Develop the required working relationships both with the PTx CMC Technical Operations and broader QA teams.
• Perform audits, write reports and follow up on audit responses and CAPA implementation.
• Establish Quality Agreements with CDMOs, associated vendors and contracted laboratories.
• Apply Quality Risk Management for key processes and systems. Identify improvement opportunities and implement changes as vital.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department
• Assist in other quality assurance related activities as agreed with management.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education / Experience

• Bachelor’s degree in chemistry, Biochemistry or related field is required.
• 7+ years’ experience in Pharmaceutical Industry in a similar function.
• Full understanding of GMP and peptide manufacturing, methods validations, specifications, and release/stability.
• Experience with Quality Assurance aspects in manufacturing processes of new products.
• Experience with effectively managing regulatory agency inspections, working with regulators, and vendor/supplier audits.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.

Knowledge / Skill / Ability

• In-depth understanding of Good Manufacturing Practices (GMP), ICH guidelines, and FDA regulations pertinent to CMC activities.
• Familiarity with the drug development lifecycle, encompassing preclinical, clinical, and commercial phases.
• Comprehensive knowledge of quality systems including CAPA, deviations, change controls, and document management.
• Strong project management capabilities, with experience in coordinating cross-functional teams to achieve quality objectives.
• Ability to evaluate and interpret complex quality data to support decision-making and regulatory submissions.
• Advanced technical writing skills for the development and review of SOPs, quality reports, and regulatory documentation.
• Capacity to collaborate effectively with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality standards are met.
• Strong communication skills, both written and verbal, to effectively convey quality-related information to stakeholders at all levels.
• Ability to travel domestically and internationally to support development activities and supplier audits, as needed (up to 20%).

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit or stand for extended periods (8+ hours per day) while performing duties, with occasional movement between workstations, which may require walking or standing for extended durations.
• Work in a team-oriented, collaborative environment that may involve regular interaction with colleagues, cross-functional teams, and management.
• Willingness to complete safety training within specified timeframes, with a focus on maintaining a safe and regulatory-compliant workplace. This includes general office safety and emergency procedures.
• Occasional use of office or production equipment that may require repetitive tasks such as typing, filing, and managing documents or materials.
• Ability to manage workload and meet deadlines in a fast-paced environment, which may involve prioritizing multiple tasks simultaneously.
• Frequent communication with team members, outside partners, and other departments may be required through email, phone or in-person meetings.

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

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