Quality Systems Manager - TPI

Description

• Lead and develop teams by fostering collaboration, aligning priorities with organizational goals, and creating a positive, inclusive work environment that promotes growth and innovation.
• Design, implement, and maintain a comprehensive risk management program aligned with ICH Q9 guidelines.
• Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement.
• Balance Quality requirements with safety, such as radiation safety, in all Quality initiatives.
• Oversee the development and implementation of data integrity policies to ensure the accuracy, reliability, and compliance of all data generated within the organization.
• Lead the implementation, qualification, and maintenance of quality systems, including QMS, EDMS, and LMS.
• Direct a team of Quality staff in the development and implementation of the Quality Program for TPI.
• Author, revise, and manage the approval of site policies and procedures related to Quality.
• Participate in Quality System audits (supplier, customer, and internal audits). Collaborate to resolve audit findings and track follow-up actions to closure.

Requirements

• Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
• Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds.
• Strong attention to detail, with the ability to interpret federal regulations, guidance, and standards. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
• Motor Abilities: Sitting and standing for extended periods, bending/stooping, grasping/gripping, fine motor control (hands).
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.
• Repetitive work: Prolonged.
• Travel required 10-20%
• Strong troubleshooting, analytical, and problem-solving skills, such as those developed in fast-paced environments including the military, and other nuclear or radiopharmaceutical environments is highly preferred.
• Special Senses: Visual and audio focused work and ability to perform role in personal protective equipment.
• Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./day.
• Minimum of 12 years of experience in either a QA function or a combination of quality assurance and radiopharmaceutical manufacturing under cGMP requirements.
• Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
• Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus.
• Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements.
• Bachelor’s degree in a life sciences discipline or a related field (or equivalent qualification through experience).
• Proven ability to develop, mentor, and grow team members, including setting clear expectations, providing constructive feedback, and supporting career development.
• Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
• Demonstrated experience working within Quality Systems (compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance) and providing collaborative customer support. Experience in a production radiopharmaceutical facility is preferred.

Benefits

• Generous Paid Time Off (PTO)
• Gender Affirmation Benefits
• Salary, eligible to participate in discretionary short-term incentive payments
• 21 days of annually accrued PTO
• Life and Disability
• Flexible Work Schedule
• 10 paid holidays
• Competitive Compensation
• Generous Holiday Schedule
• We typically place offers in the lower to middle portion of the range to maintain internal equity and allow room for growth. Any salary offered within the posted salary band is based on market data and commensurate with the selected individual’s qualifications experience. This range is specific to Washington State.
• Relocation Assistance
• 401k Plan
• Comprehensive Medical and Wellness Benefits for family or individual
• Parental Leave
• Professional and Educational Support Opportunities

Training + Development

Interview process

Visa Sponsorship

Security clearance