Job Title: Quality Assurance Manager
Job Description
In this leadership role, you will oversee all aspects of the QA team and provide guidance to direct reports. Your responsibilities will include reviewing and approving documents related to area functions, such as master records, executed records, failure investigations, CCs, SOPs, validation protocols, and summary reports. You will also be responsible for organizing QA resources assigned to functional areas to meet goals and timings, coordinating prioritization of activities with area management, and performing compliance monitoring of area operations.
You will work closely with customers to ensure that their requirements are met regarding quality. This includes participating in regulatory and customer audits, assessing disposition status for clinical and commercial products, and implementing processes to meet customer expectations.
Key Responsibilities:
* Lead the QA team and provide guidance to direct reports
* Review and approve documents related to area functions
* Organize QA resources assigned to functional areas to meet goals and timings
* Coordinate prioritization of activities with area management
* Perform compliance monitoring of area operations
* Work closely with customers to ensure their requirements are met regarding quality
Required Skills and Qualifications
To be considered for this position, you must have a strong background in data integrity initiatives/programs and a dedication to leading and training employees. A BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) is required, along with experience in a pharmaceutical/biologics manufacturing environment.
Minimum Requirements:
* 5 years of experience in the pharmaceutical industry
* 2+ years of leadership and/or supervisory experience
* BS in life sciences discipline or related field
* Experience in a pharmaceutical/biologics manufacturing environment
Benefits
We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. We strive to create an inclusive and diverse culture that values equality and diversity.
Others
We are an equal opportunity employer and welcome applications from qualified candidates without regard to race, color, religion, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.