California, US / Massachusetts, US / Remote
- Company Address: 890 Winter Street Suite 220, Waltham, MA 02451
About Kailera Therapeutics
Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions.
Job Description
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. This senior role is critical in ensuring compliance with international regulatory standards, driving quality initiatives, and supporting the organization’s strategic goals.
Responsibilities:
- Establish, develop and implement the 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 includes the QMS maintenance, SOPs, training programs, issue management and performing internal and external audits. Drive continuous improvement initiatives and projects to improve processes and the QMS.
- 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.
- 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.
- Develop, analyze, and report business metrics and highlights. If necessary, identify, communicate, and escalate GCP corporate risk, scientific misconduct, and serious noncompliance situations and follow to resolution.
- Supervisory Requirements/Responsibilities: Position will have management responsibilities.
Qualifications:
- At a minimum Bachelor’s Degree in Science or a related field. Advanced degree desirable but not required.
- Minimum of 15 years’ 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 implementing and managing Quality systems and processes infrastructure.
- Proven record of developing and maintaining successful working relationships with Sponsors and regulatory agencies.
- Required Certifications: Certification or membership to a Quality or Regulatory Association is preferred but not required.
Other Information/Additional Preferences:
- Excellent written and oral communication 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.
- Strong interpersonal skills.
- 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.
The ideal candidate will be able to work in a hybrid work environment in either our San Diego, CA or Waltham, MA office.
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.
Salary Range:
$245,000 - $320,000 USD
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, 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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