Assertio Therapeutics, Inc.

QA, Sr. Director

Lake Forest, IL, United States
Apr 27, 2018
Required Education
Bachelors Degree
Position Type
Full time
Reporting to the SVP of Operations, the Senior Director of QA is responsible for the development, implementation, and management of Depomed's internal and external quality strategy, and Quality Assurance (QA) systems to achieve compliance with company standards, cGMP, FDA regulations and guidance. The Senior Director will oversee and approve quality standards related to the manufacturing, testing, and release of Clinical Trial Materials (CTM) and commercial products. The Sr. Director of QA is also responsible for interacting successfully with Executive Management, other department heads, external suppliers, and Contract Manufacturing Organizations (CMOs) to ensure manufacturing compliance and release of API, CTM, and commercial drug products. The Senior Director of QA is the primary interface with FDA and other regulatory agencies on quality issues and during inspections.

• As Department Head of QA, ensure the efficient operation of the Quality Assurance department. Lead and mentor department staff, including training, employee development and performance evaluations.
• Act as the company authority for the interpretation of GMP regulations and guidance documents related to pharmaceutical drug product manufacturing.
• Primary spokesperson to all third parties on quality and compliance issues including regulatory agencies, corporate alliance partners, CMOs, and suppliers.
• Responsible for setting quality policy and approving GMP standards, including but not limited to: policies, procedures, analytical methods, product specifications, master batch records, raw material and API specifications, and validation documents.
• Responsible for the release (or rejection) of drug product (commercial and clinical).
• Responsible for the design, management and continuous improvement of all quality systems. These systems include change control, deviations/investigations, CAPA, complaint handling, returned goods, vendor management, quality agreements, document/records control and archive, and GMP training.
• Responsible for QA oversight and approval of validation protocols, programs, and reports for the following: process, cleaning, equipment, analytical methods, shipping, and computerized systems.
• Manage internal and external audit programs for all GXP activities.
• Establish key performance indicators for quality systems. Periodically present metrics and plans for continuous improvement to Executive Management.
• Support diligence activities for the evaluation of potential product or company acquisitions
• Develop budget and monitor expenditures.
• Domestic and International Travel; 15%


• Bachelor's degree in a scientific field
• Minimum 10 years' experience in GMP environment with at least 5 years QA experience
• Experience with manufacturing commercial pharmaceutical products is required
• Prior experience with outsourced GMP activity strongly desired
• Experience with combination products a bonus

• Understanding of the difference responsibility and authority of quality organization in a virtual company from responsibility and authority of quality unit at a contracted manufacturing organization
• Strong oral and written communication skills
• Ability to recognize and accommodate cultural differences in a work environment
• Ability to multi task
• Computer literate (Word, Excel, etc.)
• Good collaborative skills
• Skilled in risk analysis/risk management strategies

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

• Sitting - 80%
• Standing/ walking - 20%
• Travel 25%, domestic and international
• Must be able to enter clean room environments and manufacturing areas, and to follow gowning procedures
• Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
• Visual Requirements: Able to see and read PC screens and read fine print.
• Comprehension: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
• Decision Making: Ability to make decisions which have impact on the department's credibility, operations, and services.
• Communication: Ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications of major scope and impact, etc. and to make formal presentations.
• Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes.

About Us

Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.

Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.

Depomed has a clear THREE PILLAR strategy for growth: MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

As part of the transformation strategy, Depomed will be relocating its headquarters to the northern suburbs of Chicago, Illinois. Additional information about location will be shared during the interview process.

Depomed is an AA/EEO/Veterans/Disabled employer