Senior Manager, GMP Quality Assurance

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The Senior Manager, GMP Quality Assurance will collaborate internally with Quality Assurance, Regulatory Affairs, and CMC departments. As needed, they will work with external Approved Vendors to ensure oversight and compliance.  The Senior Manager will manage GMP activities related to Regulatory Standard Materials, Intermediates, Drug Substance, and Drug Product.  The Senior Manager will help develop and continuously improve Quality System Procedures related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams.  The Senior Manager will report to the Senior Director, GMP Quality Assurance.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Review and approve Vendor GMP documentation
• Review and approve Vendor and Kailera GMP Quality Events
• Review and approve master batch records
• Review executed batch records for associated Regulatory Standard Materials, Intermediates, and Drug Substance for Kailera’s program and prepare batch file for final batch disposition
• Review quality deviations, change controls, CAPA’s and other vendor documentation as needed
• Provide input on the creation of Vendor Quality Agreements
• Compile data for Quality System Reviews
• Evaluate GMP activities for continuous improvement opportunities
• Support creation and continuous improvement of Kailera procedures
• Other Quality Assurance responsibilities as assigned

Required Qualifications:

• 8+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
• Extensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex) and other agency standards and guidance as they relate to quality systems/quality assurance
• Proficient in Veeva Quality Docs and Veeva QMS
• Demonstrates proven track record of communication with internal and external Vendors
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
• Ability to identify quality issues requiring escalation
• Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with objectives
• Flexibility/ability to provide a solution-based approach to emerging challenges/changing priorities
• Clear, concise writing skills and good verbal presentation skills
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Vendors in professional and collaborative manner
• Communicate decisions and recommendations with clear justification
• Proactive approach to problem solving

Preferred Qualifications:

• Biotech experience preferred

Education:

• BA or BS degree in a scientific discipline or supplemental Quality education

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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