Principal Product Quality Leader
J
JobgetherBiopharmaceuticals
The position is available remotely in the United States, Ireland, and Puerto RicoFull-TimePrincipal
Salary$138,639 to $187,571 USD
Apply NowOpens the employer's application page
Job Details
- Experience
- Doctorate with 2+ years; Master’s with 4+ years; Bachelor’s with 6+ years; Associate’s with 10+ years; high school diploma/GED with 12+ years of relevant experience.
- Required Skills
- Quality Assurance
Requirements
- Doctorate degree with 2+ years, Master’s with 4+ years, Bachelor’s with 6+ years, Associate’s with 10+ years, or high school diploma/GED with 12+ years of experience.
- Prefer degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related discipline.
- 6+ years of experience in a regulated pharmaceutical environment, including direct GMP or technical support for biologics.
- Experience authoring or reviewing regulatory documentation such as INDs or market applications.
- Strong knowledge of cGMP requirements and international regulatory expectations.
- Proficiency in scientific data management, documentation, and technical analysis.
- Ability to assess complex information and convert into risk-based recommendations.
- Effective communication skills for presenting to leadership and regulatory authorities.
- Experience working with global, geographically distributed, and virtual teams.
- Strong problem-solving, critical-thinking, and decision-making capabilities.
Responsibilities
- Provide cross-functional Product Quality leadership for late-stage and commercial biologics programs.
- Develop and manage quality strategies aligned with manufacturing and regulatory objectives.
- Lead annual product reviews, comparability assessments, stability programs, and analytical method transfers.
- Author and review GMP and regulatory documentation, including submissions and responses.
- Evaluate complex scientific data using risk-based approaches to develop solutions.
- Support investigations, change controls, and product quality risk assessments.
- Execute and manage transactions within GMP systems.
- Communicate technical quality information to senior leadership and regulatory agencies.
View Full Description & ApplyYou'll be redirected to the employer's site
