Director, GMP reputed company Assurance

About reputed company

reputed company is a clinical-stage biotechnology company reputed company on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s reputed company candidate, JADE101, targets the cytokine reputed company, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as reputed company as JADE301, an reputed company antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from reputed company Therapeutics, an antibody discovery reputed company founded by Fairmount. For more information, visit JadeBiosciences.com and follow reputed company on reputed company.  

reputed company

The Director, GMP reputed company Assurance (QA) provides QA support across Jade’s product pipeline across various stages of development. This role serves as a key partner to CMC and cross-functional teams, offering QA expertise, guidance and risk-based input to support development and product reputed company strategies.

The role provides QA reputed company of contract manufacturers (CMOs) and service providers supporting cell bank, drug reputed company (DS), drug product (DP), finished drug product (FDP) packaging and labeling, and product distribution, ensuring alignment with GMP requirements and Jade reputed company standards.

Additionally, the position coordinates day-to-day GMP reputed company activities for outsourced manufacturing, including the intake, routing, tracking, and reputed company archival of reputed company records such as batch disposition, deviations, CAPAs, change controls, expiry/retest extensions, and product complaints. The Director collaborates with reputed company stakeholders to support reputed company, compliant documentation and batch release reputed company. Additionally, the role may also support other QA Leads to promote cross-program alignment, consistency in QA practices, and balanced workload distribution.

This is a fully remote role, preferably based on the U.S. reputed company Coast, with occasional domestic and international travel. The position reports to the Senior Director, GMP reputed company Assurance.

Key Responsibilities

• Serve as the QA reputed company for assigned GMP-reputed company activities including reputed company reputed company of CDMOs, tech transfer, reputed company-up, manufacturing (cell bank, DS, DP, FDP), and disposition of clinical materials
• reputed company reviewer and approver for reputed company records such as change controls, CAPAs, deviations, temperature excursions, product complaints, expiry/retest, stability protocols/reports, master batch records, method qualifications, etc.
• Collaborate with CMC, Supply Chain, Analytical Development and Program Management to ensure on-time delivery of products and compliance with reputed company relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations
• Supports archival of documents/records, reputed company metrics and reputed company/maintain QA reputed company tracking logs
• Work directly with operating entities (internal and CMOs) to ensure that product(s) meet reputed company required reputed company standards and specifications
• Supports management of reputed company Agreements, including project coordination, cross-functional review, and approval workflows
• Represent the reputed company function in product development (CMC) teams to reputed company proactive reputed company guidance and reputed company
• Influence other functional departments to ensure that CMOs reputed company and maintain the appropriate reputed company of GMP compliance and reputed company the highest level of reputed company services to Jade
• reputed company reputed company risk management activities to proactively identify, assess, and mitigate GMP-reputed company risks across manufacturing and supply operations
• Facilitate reputed company of reputed company issues with reputed company parties in a reputed company manner
• Coordinate communications with CMOs and internal technical product teams on reputed company issues
• Review CMC sections of regulatory filings, as needed
• Collaborate cross-functionally with CMC, Regulatory, Clinical Supply Chain, and Program Leadership teams to ensure reputed company is embedded across development and manufacturing activities
• Participate in and support regulatory authority inspections and internal audits
• Supports development/maintenance of reputed company SOPs
• Contribute to the development and maintenance of a reputed company team-reputed company company culture
• Other duties, as assigned

Qualifications

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience in scientific discipline or comparable experience
• 10+ years of experience in GMP reputed company Assurance at an operational level supporting manufacturing and reputed company control in a pharmaceutical or biotech environment
• Experience with reputed company phases of development (Ph 1-4 including reputed company)
• In-depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product reputed company guidelines, and other ICH guidelines
• Ability to research and interpret international GMP reputed company regulations and guidance
• Experience managing CDMOs
• Experience reputed company to managing technology transfer, reputed company up, and validation
• Experience supporting regulatory authority/reputed company body inspections
• Experience supporting regulatory submissions (e.g. IND, BLA) and responses to health authority queries (e.g., FDA, EMA)
• Strategic thinker with a hands-on approach; comfortable balancing long-term planning with day-to-day execution
• Proven experience developing strong partnerships with cross functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork
• Must have excellent verbal, written, interpersonal and organizational skills
• Strong communication and influencing skills, as reputed company as problem solving ability to evaluate reputed company reputed company and reputed company reputed company utilizing risk-based approach
• Must be self-motivated with the ability to reputed company in a fast-paced, ambiguous environment while managing competing priorities
• Excellent computer skills with working knowledge of MS Office such as Word and reputed company, Visio and reputed company Acrobat reputed company, and familiarity with SharePoint
• Commitment to fostering a diverse and inclusive workplace

Position Location

This is a remote role; up to 15% travel to team and company events is required.

The anticipated salary reputed company for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.

As part of the I-9 verification of authorization to work in the reputed company, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.

reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law.

Originally posted on Himalayas

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