At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.
JOB SUMMARY:
The Director of Quality Operations is responsible for providing quality oversight to all manufacturing operations in support of clinical development and commercial products, including but not limited to, Drug substance, Process Intermediates, and Drug Product(s). This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs, to achieve sustainable compliance in GxP operations.
Responsibilities
- Provide quality oversight to all manufacturing operations in support of clinical development and commercial products. Ensure all manufacturing activities in support of Drug substance, Process Intermediates, and Drug Product(s), are conducted in accordance with internal company standards and in compliance with quality agreements.
- Formulating and administering policies and standard operating procedures (SOPs) relating to the Quality Operations function and quality management system identifying opportunities for improvements.
- Ownership of real time batch record review and resolution of associated deviations prior to product disposition.
- Quality oversight of Deviations, Change Controls, CAPAs, etc., including those at the CMO sites.
- Developing and implementing appropriate quality training for the team.
- Assuring availability of all required documentation and support for the Annual Product Reviews
- Review of CMC sections for regulatory submissions to ensure accuracy and completeness. Participate in activities to assist with regulatory submissions, control strategy development and CMC strategy.
- Quality review and approval of Technology transfer protocols and final reports.
- Preparation for regulatory inspections at the CMO sites.
- Define, develop, and implement short-term and long-term strategies, goals, objectives, and tactics relating to the Quality Operations function and the quality management system.
- Review and recommend appropriate corrective action to ensure consistency with the Quality Operations function and the quality management system.
- Using incident and Corrective and Preventive Action (“CAPA”) activities and processes to drive quality improvements and respond to process and service issues.
- Represent Quality Operations function and quality management system and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assist with quality-related information related to (but not limited to) client assessments, RFPs, contracts, and other documentation.
- Assist Keros Quality Systems & Compliance team to perform GMP audits for vendors; follow through remediation plans assigned from audit observations and ensure internal and external CAPAs are completed within the mandated timelines.
- Maintain current knowledge base of regulations, corporate policies, and standards to ensure that the Quality Operations function remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
- Support strategic planning by timely communicating Quality deliverables, constraints, risks, and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
- Identify risks and assumptions in plans, anticipate problems and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track. Work effectively in team to help issue resolution. Ability to provide phase specific guidance from quality perspective, and to prioritize and multitask as necessary.
- Manage and mentor Quality operations staff to emphasize positional responsibilities, and personnel development. Must be able to coach and mentor quality personnel in necessary skills to review and approve highly technical documentation.
- Any additional duties assigned by supervisor.
Qualifications
Basic Qualifications
- Bachelor's Degree is required (Biological sciences, Engineering, or related degree); advanced degree is a plus.
- Minimum of 12 years CGMP Quality experience in the Pharmaceutical/Biopharmaceutical/ Biotechnology industry.
- Ideally a minimum of 8 years of experience in leading a Quality function.
- Ideally a minimum of 3 years of experience at the Director level with successfully managing direct reports.
- Strong knowledge of biological manufacturing process and testing.
Preferred Qualifications
- Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
- Leadership and management skills to grow and manage a high performing Quality organization.
- Demonstrated skills in project management and working with vendors and contractors.
- Strong understanding of FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.
- Proven experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, excellent interpersonal skills, organizational skills, written and oral communication skills.
- Experience developing and executing organizational change, including change management strategy and planning.
- Energetic, flexible, collaborative, and proactive; a leader who can positively and productively impact initiatives.
- Available to work in the evenings and weekends if required.
- Ability to travel up to 30%.
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$185,000 - $229,000 USD
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Recruitment & Staffing Agencies:
Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.
