Overview
Quality Management Systems and Compliance Lead (Remote) Jobs in East Hartford, CT at Pratt & Whitney
PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.
PharmaLogic offers you an exceptional opportunity to join our dynamic team as the Associate Director of Quality Assurance.
If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.
Job Title: Associate Director of Quality Assurance
Reports To: Vice President Regulatory Affairs and Quality Assurance
Role Summary:
We are seeking a highly motivated and experienced Associate Director of Quality Assurance to join our dynamic team. The successful candidate will play a critical role in ensuring the quality and cGMP compliance activities of our radiopharmaceutical drug manufacturing processes, while also contributing to the strategic vision of our organization.
Job Responsibilities and Duties:
1. Quality System Management:
Develop, implement, and maintain a robust quality management system in compliance with relevant regulatory requirements (e.g., FDA, EMA, and other applicable agencies).
Ensure the effective documentation, tracking, and review of quality records and procedures.
Continuously improve quality systems and processes to enhance product quality and operational efficiency.
2. Regulatory Compliance:
Stay up to date with evolving regulations, standards, and guidelines related to radiopharmaceutical manufacturing under 21 CFR 211.
Collaborate with regulatory affairs teams to prepare and submit regulatory filings and support inspections by regulatory agencies.
3. Quality Oversight:
Provide quality oversight for all manufacturing, QC, and QA functions at the Idaho Falls facility
Manage the QA team to provide coverage and decision-making support across a variable radiopharmaceutical manufacturing schedule, including off-shift and potential weekend operations as needed
Ensure the integrity of sterile product manufacturing through robust sterility assurance practices.
Manage QA review and approval of cGMP documentation, including procedures, protocols, deviations, out of specifications, CAPAs and change controls.
Lead, coach, and develop quality team members to maintain a high-performing, quality-focused, and engaged workforce, to maintain compliance and foster continuous improvement.
Conduct internal audits, risk assessments, and compliance assessments to identify and address quality issues proactively.
Serve as a QA representative on cross-functional project teams to ensure quality requirements are built into new processes, equipment, and products from the outset.
Promote a proactive quality culture focused on patient safety, product quality, and regulatory compliance.
4. Validation and Qualification:
Manage the validation and qualification activities for equipment, processes, and facilities to ensure they meet regulatory and quality requirements.
Collaborate with R&D and manufacturing teams to ensure seamless technology transfer from development to production.
5. Quality Metrics and Reporting:
Establish and monitor key performance indicators (KPIs) for quality, reporting on trends and providing recommendations for improvements.
Prepare and present quality reports to senior management and stakeholders.
6. Quality Investigations and CAPA:
Lead investigations into product deviations, out-of-specification results, and customer complaints, implementing effective corrective and preventive actions (CAPA).
Implement root cause analysis methodologies to prevent recurrence.
7. Supplier Quality Management:
Oversee supplier quality programs, ensuring that suppliers meet quality and regulatory requirements.
Collaborate with procurement teams to select and evaluate suppliers based on quality performance.
Job Requirements Skills Education:
Bachelor’s or advanced degree in a related scientific discipline (e.g., Chemistry, Pharmacy, or Engineering).
A minimum of 10 years of experience in quality assurance roles within the pharmaceutical or radiopharmaceutical industry.
Radiopharmaceutical experience highly preferred.
In-depth knowledge of GMP, GLP, and other relevant regulatory standards.
Experience with electronic quality management systems, inventory management systems strongly preferred.
Strong leadership and team management skills.
Excellent communication and interpersonal skills.
Experience with regulatory submissions and inspections preferred.
Ability to work varying shifts and travel up to 15%
Physical and Intellectual Requirements:
Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs and to handle frequent crawling, stooping, crouching and kneeling; ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.
Come join our winning team and begin a fulfilling career with us by applying today.
PharmaLogic is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
Benefits Include:
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Life insurance
Paid time off
Vision care
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Title: Quality Management Systems and Compliance Lead (Remote)
Company: Pratt & Whitney
Location: East Hartford, CT
