Vice President, Quality

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:

As the Vice President Quality you will develop, lead, and oversee a quality organization, including GMP, GCP, and GLP requirements. Working collaboratively with cross-functional team members across the organization, this senior role is critical in ensuring compliance with international regulatory standards, driving quality initiatives, and supporting the organization’s strategic goals.

Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Establish, develop, and implement strategic quality vision, including the Quality Management Systems. Provide Quality input to strategic goals
• Oversee the design, implement, and maintain (GxP) programs and framework, which include Veeva Quality Docs and QMS maintenance, SOPs, training programs, issue management, and performing internal and external audits. Drive continuous improvement initiatives and projects to improve processes
• Lead coordination with regulatory agencies and other external auditors to build trust and confidence in the company’s quality systems and processes.  Prepare for and lead regulatory inspections. Serve as the company quality technical expert with respect to audit findings and provide company risk assessments/management as needed
• Oversee the development, maintenance, and continuous improvement of processes and procedures, along with the implementation of quality event and CAPA processes and systems
• Develop, execute, and maintain risk-based audit strategies to ensure that systems and clinical trial activities performed are conducted in compliance with applicable regulations, ICH/GCP guidelines, and procedures. Identify areas of failure or gaps within processes, ensuring that appropriate levels of control are in place to meet defined regulatory requirements, customer expectations and business objectives
• Foster and promote a GXP-compliant environment with internal and external stakeholders. Provide expertise and guidance in interpreting and implementing regulations and GxP research guidelines to ensure compliance. Ensure SOPs are developed in manner which allows for flexibility and compliance.
• Develop, analyze, and report business metrics and highlights. If necessary, identify, communicate, and escalate corporate risk, scientific misconduct, and identified noncompliance situations and follow to resolution
• This position will have management responsibilities

Required Qualifications:

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry in a quality or related field
• Strong GxP knowledge and strong understanding of relevant regulatory requirements
• Hands-on experience with developing, implementing, and managing quality systems and processes infrastructure
• Proven record of developing and maintaining successful working relationships with sponsors and regulatory agencies
• Proven record of collaboration, excellent communication, and working in fast-paced environments
• Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment
• Excellent written and oral communication skills, as well as strong interpersonal skills
• Strong organizational, problem-solving, and analytical skills
• Versatility, flexibility, and a willingness to work within constantly changing priorities
• Proven ability to handle multiple projects and meet deadlines
• Ability to deal effectively with a diversity of individuals at all organizational levels
• Creative, flexible, and innovative team player
• Ability to work independently and as a member of various teams and committees
• Good judgement with the ability to make timely and sound decisions 

Preferred Qualifications:

• Certification or membership to a Quality or Regulatory Association is preferred but not required

Education:

• Bachelor’s degree in science or a related field. Advanced degrees are desirable but not required

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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