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About
Salary range:TBD Principal Responsibilities Building Quality Assurance Team and Capabilities Develop and implement a comprehensive quality strategy aligned with business objectives. Lead the QA function, including Supplier Management, Audits, Quality Systems, Document Control, Training, as well as GMP/GCP/GLP compliance. Build, mentor, and lead a high-performing quality team, fostering a culture of accountability and continuous improvement. Provide quality oversight to enable contract manufacturing and clinical trials. Develop and manage quality budget Implementing Quality Management Systems Oversee the development, implementation, and maintenance of the Quality Management Systems including Quality Management Review Implement and integrate risk management strategies throughout the product lifecycle. Identify and mitigate risks associated with quality and compliance associated with product lifecycle. Drive continuous improvement of document control systems and promote adherence to company policies, SOPs, and guidelines. Identify and anticipate trends in quality issues, collaborate with leadership team to implement continuous improvement and quality initiatives Analyze Key Performance Indicators (KPI’s) and report status of quality systems to Executive Committee Responsible for internal and external audit preparation, training, and serve as lead FDA/Regulated Authority liaison during audits Supporting CMC programs and Clinical Trials Support clinical trial operations by ensuring all aspects of ICH GCP are followed Provide clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations Provides strategic leadership and direction for clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs). Provide QA leadership on project teams and contract manufacturers. Direct all aspects of quality support and strategy for the project team on the designated product(s). Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective. Actively monitor ongoing contractor-related manufacturing, quality control testing, and other activities. Provide feedback to stakeholders in a timely manner as per established Quality Agreements. Review and approve partner/contractor GLP/GCP/GMP quality agreements and documentation
Qualifications, Education & Experience
Bachelor’s degree in chemistry, biochemistry, pharmacy, pharmacology, or related scientific discipline required. Master’s Degree, PharmD or PhD preferred. At least 18 years of Quality Assurance experience in FDA regulated industry Prior experience with FDA submissions including IND and early-stage experience required. Prior expertise in Radiopharmaceutical desired. Competence in FDA, international GMP and GCP requirements. Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organizations. Experience in leading Quality function in fast paced early clinical stage companies. Skills and Abilities
Builds a learning environment that recognizes the value of each contributor and promotes a solutions-oriented mindset. Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes to create the most efficient and effective methods to deliver quality clinical trial services. Willingness to collaborate with team to identify and implement best practices for optimizing performance. Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. Strong leadership skills in leading team members and vendors. Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight. Strong organizational, communication and interpersonal skills Ability to prioritize, delegate and execute quality responsibilities and deliverables to meet project deadlines.
At Abdera, we recognize the importance of attracting and retaining the best talent, and we're committed to offering competitive compensation and comprehensive benefits tailored to your needs. Here’s what you can expect when you join our team in the U.S.:
Competitive Base Pay: Our expected base pay range for this position is $XXX - $XXX (USD), plus performance-based bonuses. Comprehensive Benefits: Health, Dental, Vision, Prescription drug coverage, Basic Life and AD&D insurance, both Long-Term and Short-Term disability 16 paid company holiday, 20 days of PTO and 6 sick days to ensure your well-being, as well as a 401k plan with up to 3.5% company match, equity and bonus to help secure your financial future. Personalized Pay: Your individual pay will be determined by your job-related skills, experience, and relevant education or training, ensuring you receive fair and competitive compensation. Work-Life Balance: We also offer a hybrid work schedule with 3 days on-site along with development and growth opportunities. At Abdera, we value our employees and strive to create an environment where you can thrive both professionally and personally. Join us and be part of a company that cares about your growth and well-being.
Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.
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Languages
- English
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