Senior Manager/Associate Director, QA Operations

Your experience includes… 

• BA/BS in scientific discipline and 12+ years of demonstrated GMP Quality experience in the pharmaceutical / biopharmaceutical industry; or MS degree and 10+ years of relevant experience
• Experienced with QA oversight of GMP manufacturing and Quality Control testing

You are interested in… 

• Executing QA on the floor support for in-house manufacturing activities
• Reviewing and approving master and executed batch records
• Reviewing and approving method qualification protocols and reports, test methods, certificates of analyses and product stability related activities
• Overseeing GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; providing oversight of appropriate CAPAs associated with deviations and investigations
• Providing oversight for the documentation of internal changes
• Supporting timely batch release. Overseeing the review and approval of all GMP related documentation, and ensuring compliance with regulatory requirements
• Reviewing and approving internally authored documents- e.g. SOPs, work instructions, forms
• Participating in risk assessment activities associated with batch release

About you: 

You are a skilled individual who can independently lead internal QA Operational activity. As a member of the Quality Assurance team, you will provide Quality Assurance expertise and act as the subject matter expert for oversight for internal Manufacturing and QC activities. You enjoy being on-site to support site-related activities. You promote a safe work environment and drive continuous improvement activities and demonstrate appropriate escalation methods while troubleshooting. You are experienced in collaborating with cross-functional teams (including Manufacturing, Quality Control, Quality Systems, Materials Management, and Facilities).

Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence. 

 

Meet your Manager:

All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening. 

Dana Blades, Director, Quality Assurance

Dana has over a decade of extensive experience in both Quality Assurance and Quality Control functions. He has a deep understanding of global regulations and best industry practices. He has a bachelor’s degree in biology from Rivier University. Dana has also obtained his MBA in Management from Rivier University. Dana leads the Quality Assurance team, which includes supporting in-house manufacturing, QC testing, facility related activities and oversight of external operations.

Meet our Leadership Team and Board of Directors 

Meet your Talent Partner:

Annie Edminster, Employee Experience and Talent Lead

Originally from Maine, Annie obtained her Bachelor of Science from Syracuse University. She spent eight years in Biotech, Engineering and Tech agency recruitment, then joined Tessera in 2022. Annie loves watching her new hires grow in their careers and getting to know her colleagues from all over the world! She lives in New Hampshire with her robot-building husband, two feisty daughters, and two Siberian cats.  

 

Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits currently include group medical, vision and dental coverage, group life and disability insurance, 401(k) with company contribution, tuition reimbursement, and much more.

Company Summary:

Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

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