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Director of GMP Quality Assurance - Conshohocken, United States - Madrigalpharma
Description
This position will be responsible for Quality Assurance oversight of all analytical aspects.The primary responsibilities will be to ensure quality and accuracy of analytical data and compliance to approved methods and regulatory filings.
This position will participate in technology transfer, participation in audits and inspections, and being an effective liaison to internal cross-functional groups, QA/CMC consultants, and external partners.
This position reports into the Executive Director of GMP Quality Assurance.Position Responsibilities:
Work collaboratively with internal CMC group and the analytical departments of vendors to obtain analytical reports and relevant raw data.
Review, and approve as applicable, analytical methods for QA.
Review analytical reports including, but not limited to CoA's, QC Reports, Stability Reports for data accuracy and compliance to approved methods, protocols and specifications as applicable.
Implement and maintain a system for internal specifications for API intermediates, final API, and drug product.Participate in change control process for analytical methods and specifications.
Participate in OOS investigations and approve the final investigation for QA.
Archival of all analytical documentation in Madrigal's document system (Veeva QualityDocs).
Support creation of or revision to sections in regulatory submission that pertain to analytical data.
Ensure that analytical methods, protocols, and specifications are in compliance with applicable regulatory guidance and standards (e.g., ICH, USP, CFR, EP).
Participate in the disposition process for API intermediates, final API, and drug product.Maintain required knowledge of applicable regulations, guidelines, and company standards and procedures.
Provides input to regulatory responses.
Participate in preparations for (corporate and third-party) inspection-readiness.
Qualifications and Skills:
Strong GMP knowledge
Strong experience in directing or overseeing all aspects of analytical testing, from method development through validation and routine testing
Ability to make rational, timely, and compliant risk-based decisions
BS and/or MS in a scientific discipline
Skilled in developing collaborative internal and external relationships
Excellent troubleshooting skills with the ability to solve complex problems
Visionary leadership skills and ability to interact with all levels
Strong knowledge and experience in leading the design, development, and/or reviews of CMC QA standards and procedures (i.e., policy documents and SOPs).
Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment.
Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands.
The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need.Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source.Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites.
These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates.
Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Interviews with Madrigal are conducted via the Zoom platform.Please also note that any correspondence with regard to employment would come from an authorized email address or from an email address from one of our trusted search firm partners.
We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts.If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you:
do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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