Responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at contract manufacturing organizations (CMOs In partnership with QC, Regulatory Affairs, Contract Manufacturing and Project Management).
The QA Sr Manager will ensure that products are manufactured in accordance with cGMPS, regulatory commitments, Assertio requirements and internal procedures.
Responsibilities Essential Job Function Approve master batch records, specifications, qualification & validation protocols and reports, labels Approve/release (or reject) commercial and clinical batches Provide guidance and make recommendations regarding issues that relate to manufacturing products in accordance with all applicable regulations and current industry standards Approve deviations, ensuring that root cause analysis and corrective actions are adequate Audit CMOs, contract test laboratories and/or raw material suppliers Manage product complaints according to procedure Establish or optimize quality systems Leads the development, revision and implementation of procedures to address issues unique to product transfers to external business partners Perform risk analysis to assess inadvertent events that may impact product identity, strength, quality, purity Advise and/or manage risk management strategies Perform due diligence assessments Author quality agreements and standard operating procedures Must be capable of working independently with minimum supervision Represent quality management at CMOS Additional Responsibilities/Duties Establish/maintain effective working relationship with CMOs/business partners Partner with ‘CMC' team members to ensure a cohesive unit aligned in expectations for CMO deliverables Travel estimated 25% Qualifications Education and Experience Bachelor's degree in a scientific field Must be authorized to work in the U.S.
on a permanent basis without sponsorship in the future Minimum 10 years experience in GMP environment with at least 5 years of QA experience Experience with manufacturing commercial pharmaceutical products is required Prior experience with outsourced GMP activity strongly desired Experience with combination products a bonus Skills and Abilities Strong oral and written communication skills Ability to recognize and accommodate cultural differences in a work environment Ability to multitask Computer literate (word, excel,etc.) Good collaborative skills Skilled in risk analysis/risk management strategies Applies in-depth understanding of quality principles to complex GMP issues Ability to make persuasive arguments supporting sensitive decisions while maintaining good working relationships Assertio Competencies Include Decisions and Judgment : Independently completing assigned tasks by gathering relevant information systematically and considering a broad range of issues or factors when making decisions.
Ownership and Initiative : Assumes personal ownership and accountability for business results and solutions.
Organizes work based on company/department goals.
Develops alternative strategies when confronted with obstacles.
Plans and organizes work so that timelines are met or exceeded.
Communication skills : Expresses ideas and information effectively and constructively.
Provides accurate and timely information to others within the department and across functional groups.
Demonstrates attention to and understanding of others' comments, questions, and views.
Teamwork : Establishes and maintains cooperative and productive working relationships.
Proactively and constructively resolves disagreements.
Shares recognition and credit with others.
Acts with integrity and earns the trust of others by dealing with them respectfully and honestly.
Shows awareness and considers the opinions of others.
Physical/Mental Demands Sitting - 80% Standing/walking - 20% Travel 25% - domestic and international 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.
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 hrassertiotx.com or call 224-441-6867 for assistance.