Sr. Manager, QA
- Employer
- Assertio Therapeutics, Inc.
- Location
- Lake Forest, IL, US
- Start date
- Sep 14, 2019
View more
- Discipline
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest
Job Details
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.
Company
Assertio reflects an aspirational mindset that is forward thinking, energetic, and entrepreneurial in spirit. The Assertio mission of advancing patient care is reflected in our three-pillar strategy:
Maintain
Grow
Build
Maintain
In December 2017, the Company announced the signing of a definitive Commercialization Agreement with Collegium Pharmaceutical under which Collegium will commercialize the NUCYNTA pain franchise and Assertio will receive a royalty rate on all NUCYNTA revenues based on certain net sales thresholds.
Our long-term strategy is to continue to identify, license, develop and market distinctive products that offer enhanced therapeutic options for patients in need—all while maintaining the highest ethical standards in all our business practices.
We have developed and are licensing Acuform® technology, a patented oral delivery technology that allows for targeted, extended release of compounds into the upper GI tract. Acuform is currently utilized in four marketed products, including NUCYNTA ER and Gralise. To date, we’ve also licensed Acuform to six partners
Grow
We currently market three FDA-approved products for various neurological conditions.
Build
We have created a new specialty products business unit, with the objective of assembling a portfolio of specialty/orphan drugs that address the unmet needs of patients, physicians and payers. Our initial focus is the development of Cosyntropin (synthetic ACTH depot), a unique, late-stage product that, upon approval, will provide U.S. patients, physicians and payers with an alternative option.
NASDAQ: ASRT
- Website
- http://www.assertiotx.com/
- Phone
- 224-419-7106
- Location
-
100 South Saunders Road, Suite 300
Lake Forest
Illinois
60045
US
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