Homeoffice Senior Pharmaceutical CDMO Quality Analyst na Padagis

Our Contract Development and Manufacturing Organization (CDMO) requires a seasoned Managing Quality Professional with more than 10 years of experience in pharmaceutical manufacturing, specializing in areas such as sterile processing and visual inspection. The candidate will be instrumental in upholding our commitment to excellence by leading our external Quality teams in ensuring our products not only meet but exceed quality standards.

Job duties:

• Develop and enhance relationships with CDMOs to effectively build a collaboration and partnership.
• Provide Direct supervision and enhancement of the Quality Management System (QMS) to assure consistent adherence to cGMP, CFR, USP, & ISO quality standards (Other world-wide regulatory requirements experience preferred).
• Manage Padagis Source Approval process to bring new CDMOs into the Padagis Quality Management and Enterprise systems.
• Independently Scope, Plan, Schedule, and Perform auditing of CDMO as Lead Auditor, issuing observations and approval of observation responses.
• Formulate and enforce quality protocols and procedures, aiming to optimize product quality and reduce quality-related risks.
• Govern sterile processing operations to maintain sterility assurance levels and conform to aseptic principles.
• Supervise and refine visual inspection processes to guarantee all products meet USP and FDA requirements.
• Spearhead investigations into quality events, discrepancies, deviations, and customer complaints, implementing swift and effective CAPA measures.
• Lead Quality and Technical aspects of drug product Technical Transfers of products from CMO to CMO or CMO to into Padagis internal systems.
• Review and approve CDMO documents (i.e. deviations, change controls, protocols, reports, etc.).
• Author and Lead Quality Assurance Agreement development and collaborate with the CDMO, Padagis Legal, Regulatory Affairs, and Pharmacovigilance Teams to complete this Agreement with no impact to overall product launch schedule.
• Work robustly with various teams such as Regulatory Affairs, R&D, Operations, and Supply Chain to embed quality considerations throughout all stages of product development and lifecycle phases.
• Mentor and cultivate talent within the Quality department, promoting a culture rooted in excellence and responsibility.
• Provide support to CDMO during and after FDA inspections and support them in observation responses and remediation of any observations.
• Support and provide QA and Technical direct input to Padagis Legal Team for matters involving CMO and/or externally manufactured Padagis products.
• Other duties as assigned.

Minimum qualifications:

• Bachelor’s degree in scientific discipline or closely aligned field (Chemistry, Biology, Pharmacy, Engineering).
• Minimum of 10 years industry experience directly or indirectly supporting aseptic pharmaceutical manufacturing.
• Subject Matter Expertise in key areas of drug product manufacturing, packaging, release testing (i.e. formulation, filling, sterile processing, visual inspection, analytical methods and specifications).
• Profound knowledge of regulatory guidelines including FDA, USP, EMA, ICH, cGMP, ISO standards and related regulations.
• Advanced analytical acumen with a solid grasp of quality risk management approaches.
• Outstanding communications, problem-solving, and organizational talents.
• Proven capability to work in concert with teams and influence cross-functional teams.
• Proficiency with Quality Management Software (QMS) tools and Microsoft Office applications.
• Minimum of 5 years demonstrated experience in performing Lead Auditor roles and responsibilities 

Preferred qualifications:

• Master's degree
• ASQ-CQA Auditor Certification

Core Competencies;

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five “core” competencies. We strive to bring employees on board the journey with us who exemplify these key competencies:  

• Service delivery – Understand who your internal and external customers are, identify their needs, and deliver value above their expectations.
• Active collaboration – Seek opportunities to work together across teams, function, business units, and geographies to seek success.
• Demonstrate agility – Proactively identify changes in our environment and act quickly, leading or embracing change.
• Think differently – Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists.
• Excellent execution – Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes

About us:

At Padagis our focus is on health care products that improve people’s lives. We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products. It’s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

What’s Next:

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.