Sr. Manager, Quality Assurance - South San Francisco, CA | Biospace
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Sr. Manager, Quality Assurance

Rigel Pharmaceuticals, Inc.

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Location:
South San Francisco, CA
Posted Date:
7/25/2017
Position Type:
Full time
Job Code:
R17-002-19-01
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QA, Quality, Quality Assurance,

Job Description

ABOUT RIGEL:
Rigel is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. Our business strategy is to transition to a commercial-stage company with our Phase 3 results from fostamatinib in immune thrombocytopenic purpura (ITP). We continue to build an extensive portfolio of products in immunology and oncology, monetizing select assets through attractive partnerships. Rigel plans to submit an NDA for Fostamatinib.  The Sr. Manager, Quality Assurance will work closely with the Sr. Director of Quality Assurance to ensure inspection readiness and provide QA support for validation and manufacturing of drug substance/product.


POSITION SUMMARY:
This position will report to the Sr. Director, Quality Assurance and will manage the Quality aspects of clinical and commercial drug manufacturing, validation, and analytical testing at contract manufacturers.  This position will also be responsible for the management, operation, and upkeep of the Quality Assurance and Document Control System to support GxP (GMP, GLP, & GCP) programs.  Responsible for assistance in vendor oversight and Regulatory inspection readiness.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
Quality Responsibilities:
•   Establish internal SOPs applicable to internal functions as well as outsourced functions
•   Responsible for Assisting in PAI and Regulatory inspections readiness
•   Provide QA support for drug substance/product validation and manufacturing of commercial drug substance/product at CMOs
•   Provide effective QA support for the manufacturing and disposition of clinical and commercial lots
•   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, master batch records, executed batch records from CMOs.  Work with the CMO to resolve deviations and review comments to the CMO
•   Ensure that clinical and commercial drug substance/product meet all required specifications
•   Provide quality assurance support in the technology transfer, scale-up, validation and manufacturing at CMOs
•   Ensure compliance with the quality systems such as deviations, change control, investigations, and CAPA resolutions
•   Management of assigned QA operation tasks in accordance to SOPs (e.g., trending report, training program)
•   Independently interacts with other groups to proactively address compliance concerns and resolve problems
•   May participate on cross-functional compliance improvement projects
•   Performing internal and external audits
•   Be able to work with a paper based system

Document Control Responsibilities:
•   Maintaining the document control system. Duties include but are not limited to supporting document change control activities, document generation, tracking and distribution for review, approval and filing
•   Ensure Document Control and Training systems are in compliance

ADDITIONAL RESPONSIBILITIES:  
•   Perform Annual Product Reviews
•   Ability to file a Field Alert Reports (FAR)
•   Develop Quality Management Systems

Requirements

KNOWLEDGE AND SKILL REQUIREMENTS:
•   Minimum BS/BA in Chemistry, Biology or other relevant discipline
•   10+ 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
•   Prior working experience maintaining training program activities
•   Strong understanding of cGMPs (21 CFR 210, 211) 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 participates 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