Associate Director/Director, GMP Quality Assurance (Drug Substance)

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.

Preferred location is Waltham, MA or San Diego, CA. Will consider remote candidates.

What You’ll Do:

The Associate Director/Director will collaborate with the CMC department and external Approved Vendors (Vendor) to ensure oversight and compliance.  Associate Director/Director will manage GMP activities related to Regulatory Standard Materials, Intermediates, and Drug Substance.  Associate Director/Director will help develop, continuously improve, and maintain Quality Systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams and management.  The Associate Director/Director will report into the Head of Quality Assurance.

Responsibilities:

• Plan and oversee day-to-day GMP activities of the Quality function.
• Ensure appropriate Quality oversight of external Vendors.
• Active member of GMP Vendor meetings.
• Review and approve Vendor GMP documentation.
• Review and approve Vendor and Kailera GMP Quality Events.
• Review and approve executed batch records for associated Regulatory Standard Materials, Intermediates, and Drug Substance for Kailera’s program and determine final batch disposition.
• Support adherence to Vendor Quality Agreements.
• Generate metrics and compile data for Quality System Reviews.
• Participate in Kailera GMP sub-teams as the Quality representative.
• Evaluate GMP activities for continuous improvement opportunities to the Kailera Quality System.
• Provide QA review of CMC related sections of regulatory filings.
• Coordinate and manage compliance related activities in preparation for Health Authority inspections and support interactions during Health Authority inspections.
• Other Quality Assurance responsibilities as assigned.

Required Qualifications:

• 12+ 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.
• Experience with Health Authority filings and/or inspections.
• Proficient in Veeva QualityDocs and Veeva QMS.
• Proficient in Word, Excel, PowerPoint, SharePoint.
• Demonstrates proven track record of leadership, communication, and motivation skills 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.
• Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with organization objectives.
• Solves conflict and addresses workplace issues in professional and collaborative manner.
• 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.
• Communicate decisions and recommendations with clear justification.
• Ability to resolve day-to-day issues efficiently while maintaining compliance.
• Independently determines and develops approach to solutions.
• Proactive approach to problem solving.

Education:

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

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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