Assertio Therapeutics, Inc.

Sr. Manager, QA

Location
Lake Forest, IL, US
Posted
Sep 14, 2019
Ref
2019-1046
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Responsible for oversight of quality aspects related to Supplier Oversight including the Audit Program, Quality Technical Agreement (QTA) Management and Supplier Qualification Management. Also responsible for oversight of Quality Systems including Document and Training Management, QMS Administration, APQR Management and Management Review. Supports oversight of manufacture of API, excipients, commercial and clinical drug products at contract service providers (CSPs). Under the direction of senior QA leadership, the QA Senior Manager will ensure that Assertio Quality Systems are in accordance with cGMPs, regulatory commitments, Assertio requirements and internal procedures.

Responsibilities

Essential Job Function
  • Administers the Supplier Management system including the audit program, supplier qualification process and Quality Technical Agreements for CSPs (i.e. contract manufacturers, contract testing laboratories, and API/Excipient Suppliers)
  • Administers the Document and Training Management systems
  • Administers the QMS system including Audit, Change Control, Quality Event, Complaint and CAPA Modules
  • Reviews master batch records, specifications, qualification and validation protocols and reports, labeling materials
  • Supports product complaint and manufacturing deviations as needed
  • Administers quality systems including FAR, Recall/Product Withdrawal, Management Review Program, and Annual Product Quality Review (APR) Program
  • Supports Regulatory Inspections and Audits of Assertio
  • Authors and revises controlled documents as needed
  • Performs other QA organization duties as required to provide cross functional support to Regulatory, Clinical, Manufacturing, Pharmacovigilance, Supply Chain, and Medical Affairs
  • Must be capable of working independently with minimum supervision

Additional Responsibilities/Duties
  • Attend seminars, shows, lectures, etc., that are industry or job related


Qualifications

Education and Experience
  • BS degree with equivalent experience in related field required
  • Must be authorized to work in the U.S. on a permanent basis without sponsorship in the future
  • A minimum of 8 years of experience in pharmaceutical GMP environment with experience in Quality Assurance
  • Experience with manufacturing commercial and clinical pharmaceutical products is required; Experience with external/contract service providers is highly desired


Skills and Abilities
  • Strong influence management skills including comfort operating in a highly matrix-based environment
  • Effective communication skills (verbal, written, interpersonal, organizational), capable of setting priorities
  • Ability to multi task
  • Computer literate (word, excel, etc.)
  • Works well within team environment
  • Ability to work cooperatively with minimal supervision with internal and external groups on multiple projects


Assertio Competencies Include
  • Integrity
  • Decisions & Judgment
  • Ownership & Initiative
  • Adaptability & Change Readiness
  • Teamwork & Collaboration

Physical/Mental Demands

Physical Requirements
  • Sitting: Yes
  • Standing/ walking: Yes
  • Repetitive motion: Keyboard work
  • Visual Requirements: Must be able to see clearly
  • Lifting: no more than 40 lbs

Mental Requirements
  • Ability to understand, remember, and apply oral and/or written instructions or other information
  • Ability to understand, remember and communicate routine, factual information
  • Ability to organize thoughts and ideas into understandable terminology
  • Ability to organize and prioritize own work schedule
  • Able to complete forms, use existing form letters and conduct routine oral communication
  • Able to compose letters, outlines, memos and basic reports, and to orally communicate technical information
  • Ability to count accurately

Accommodations for Applicants with Disabilities

Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.