Job Description
Job Description
Job Description
POSITION SUMMARY:This position reports to the Senior Director, Quality Assurance and will independently manage the Quality aspects of commercial and clinical drug manufacturing, validation, and operations at the contract manufacturers. This position is responsible for the management, operation, and upkeep of the Quality Assurance activities and support Inspection readiness activities for GxP (GMP, GLP, & GCP) programs. This position is also responsible for assistance in vendor oversight and day to-day QA operations and fosters a culture of continuous improvement in all aspects of GxP Quality, including the development and administration of policies and practices that address quality issues throughout the organization and enhancement of electronic systems and new technologies.
Salary Range:
National $185,000 - $215,000
Premium (NY/CA) $200,000 - $240,000
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform quality oversight of cGMP activities which include independently setting up and/or optimizing processes for, drug substance and drug product manufacturing, labeling, batch record review and lot disposition
- Provide direction for complex deviations and other investigations and CAPAs in support of batch release, inspection readiness and regulatory findings including tracking closure of compliance issues
- Independently perform and/or manage batch release activities for commercial and clinical production including but not limited to review of batch records, analytical data, certificates of analysis, and other documents (e.g., method validation protocols/reports, product specifications, change controls, etc.) as needed for consistency with applicable regulations and for compliance with company's GMP Quality System
- Provide status reports, including relevant quality metrics and participate in the management review process
- Identify and support continuous improvement projects in collaboration with CMC, QC and RA to achieve quality, reliability and efficiency improvement objectives
- Support or lead implementation and upgrades of digital tools and systems supporting Quality
- Manage quality assurance team and consultants, as assigned
- Establish collaborative relationships with internal and external stakeholders to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner
- Establish internal SOPs applicable to internal functions as well as outsourced functions
- Assist in any Regulatory inspections’ readiness
- Establish and ensure that policies at Rigel and CMOs adhere to cGMPs, and regulatory requirements of FDA, EMA and other regulatory agencies as required
- Oversee QA Review of process validation protocols, validation data and validation reports
- Provide quality assurance support in the technology transfer, scale-up, validation and manufacturing at CMO.
- Manage assigned QA operation tasks in accordance with Rigel’s SOPs (e.g., trending report, training program)
- Independently interact with other groups to proactively address compliance concerns and resolve problems
- Able to participate in cross-functional compliance improvement projects
- Perform internal and external audits
- · Able to work with electronic and paper-based systems
ADDITIONAL RESPONSIBILITIES:
- Perform Annual Product Reviews
- Ability to file Field Alert Reports (FAR)
- Develop Quality Management Systems
KNOWLEDGE AND SKILL REQUIREMENTS:
- Minimum BS/BA in Chemistry, Biology or other relevant discipline
- 12+ years QA or equivalent experience in the Pharmaceuticals/ or Pharma and Device, and at least 4 years of leadership and management experience
- Prior hands-on experience establishing and/or maintaining a document control system is required. Experience with implementing new technologies is preferred.
- Prior working experience maintaining training program activities
- Strong understanding of cGMPs (21 CFR 210, 211), ICH guidelines and ISO concepts
- Understanding of basic scientific/technical concepts
- Good analytical skills
- Clear, concise writing skills and good verbal presentation skills. Including but not limited to Word, Excel, MS Office and SharePoint
- Excellent organizational skills and attention to detail
- Ability to interact constructively and efficiently with co-workers
- Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Demonstrates strong understanding of procedures and methods for review function
- PAI readiness or BIMO readiness are preferred
- Ability to work under tight deadlines
- May participate on project teams and actively participate in cross-functional compliance improvement projects
- Works under only general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives
- Hands-on experience and proficiency in writing Deviations, Change controls, CAPAs, Investigations, SOPs and other controlled documents
WORKING CONDITIONS:
- PHYSICAL DEMANDS : While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
- WORK ENVIRONMENT : The noise level in the work environment is usually moderate. Some travel may be required.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
Job Tags
Contract work, Work experience placement,