Associate Director/Director, Clinical Quality Audits

The Associate Director/Director, Clinical Quality Audits at Scholar Rock holds several key responsibilities that ensure our clinical audit programs are top-notch. This role involves leading the Clinical Quality Audit Program, managing a team of auditors, and executing audits for Investigator Sites and vendors, all while closely collaborating with Clinical Operations to adhere to company SOPs. Importantly, you will oversee the internal audit program and aid in preparing for regulatory inspections, delivering consultations on corrective actions arising from audit observations. Being in this role requires adept management of audits and a commitment to promoting best practices across the organization.

To qualify for the Associate Director/Director, Clinical Quality Audits position at Scholar Rock, candidates must possess a BA/BS degree, although an advanced degree is advantageous. You should have a minimum of 8 years of experience in the biopharmaceutical R&D field, with 4 years focused on clinical quality assurance and at least 2 years of audit management experience. Demonstrating familiarity with FDA regulations and ICH guidance for GCP, GLP, and other areas is crucial, along with experience in conducting audits and drafting Standard Operating Procedures (SOPs). Strong communication skills and an eagerness to thrive in a fast-paced environment are also essential.

The Associate Director/Director of Clinical Quality Audits plays a crucial role in reinforcing quality assurance processes, which directly affect patient care at Scholar Rock. By leading the Clinical Quality Audit Program, this position ensures that all clinical operations comply with the highest standards of quality and safety. The audits conducted help to identify and rectify issues that could jeopardize data integrity or patient safety, thereby safeguarding the interests of study subjects and enhancing trust in our clinical programs. It's about creating an environment where innovative treatments can develop seamlessly, ultimately benefiting patients who are in dire need of effective therapies.

In the role of Associate Director/Director, Clinical Quality Audits at Scholar Rock, you can expect a dynamic, remote working environment that values collaboration and innovation. We pride ourselves on our diverse and inclusive culture, which empowers employees to share their ideas and work together towards common goals. Fast-paced and driven, the environment encourages personal growth and professional development while championing quality management principles that support our commitment to impactful therapeutics. Whether collaborating across teams or leading your own, you will engage in meaningful work that directly influences the trajectory of patient care.

Scholar Rock is a truly remarkable workplace for an Associate Director/Director, Clinical Quality Audits due to its unwavering commitment to scientific innovation and patient welfare. The opportunity to be part of a pioneering company that significantly impacts treatment options for underserved diseases sets Scholar Rock apart. Employees are not just numbers; they are part of a mission that prioritizes their contributions toward groundbreaking therapies. The culture of support, diversity, and collaboration ensures that every team member’s voice is heard, fostering an environment where talent thrives. If you're looking for a position that offers both professional challenges and the chance to make a tangible difference, consider joining us at Scholar Rock.

When interviewing for the Associate Director/Director position, focus on your systematic approach to ensuring compliance. Highlight your understanding of FDA regulations and your experience applying them during audits. Discuss how you establish SOPs and your strategy for training audit staff on regulatory requirements. Providing specific examples of past experiences where you successfully navigated compliance challenges will demonstrate your capability.

In answering this question, emphasize your leadership style and the methodologies you employ to manage your auditing team effectively. Explain how you've motivated team members and aligned their goals with the company’s objectives. Use examples to illustrate successful team projects you’ve overseen, including challenges you overcame. Highlight your commitment to quality and collaboration.

A thoughtful response would include a discussion on key performance indicators like KQIs and KPIs that focus on audit effectiveness, CAPA timelines, and audit observation closure rates. Elaborate on how you would monitor and report on these metrics to inform continuous improvement within the Clinical Quality Audit Program, and relate these metrics to their impact on patient safety and data integrity.

Prepare to describe a specific instance where you identified a complex issue during an audit, detailing your thought process and the steps you took to resolve it. Emphasize your analytical skills and your ability to collaborate with stakeholders to develop a robust resolution. The key is to showcase your problem-solving capabilities and the positive outcomes derived from your actions.

Discuss strategies you have implemented in your past roles to foster a quality-centric culture, especially in a remote setting. This could include regular communication, virtual training sessions, and the use of digital tools to ensure transparency. Mention the importance of creating an inclusive atmosphere where team members feel comfortable discussing quality issues and sharing improvement ideas.

Here, you should discuss a structured approach to developing SOPs, including stakeholder engagement, reviewing existing SOPs for relevance, and ensuring they meet regulatory requirements. Mention the importance of incorporating feedback loops where team members can suggest improvements based on operational experience. Being able to articulate a clear, organized process will reassure the interviewers of your expertise.

Talk about your methods for prioritization and project management, such as the use of scheduling tools, delegation, and maintaining open communication with your team and stakeholders. Describe a particular situation where you effectively managed competing deadlines and how you successfully delivered quality results amidst the pressure.

Discuss the significance of establishing strong relationships with other departments, such as Clinical Operations and Pharmacovigilance. Provide examples from your experience on how collaboration led to improved outcomes or innovative solutions. Highlight how effective communication across functions enhances the overall quality of the audit program and contributes to achieving organizational goals.

Preparation for regulatory inspections can be critical in this role. Explain how you conduct internal audits, ensure all documentation is in order, and engage in mock inspections with your team. Share your approach to training and preparing your team to respond accurately to inspection queries, highlighting the importance of teamwork and preparedness.

Articulate your enthusiasm for joining Scholar Rock by connecting with the company’s mission and its commitment to developing groundbreaking therapies. Share personal values that resonate with Scholar Rock's vision, and explain how your skills and experience align with the company’s needs. This is an opportunity to reflect your passion for quality assurance in the biopharmaceutical industry and the positive impact it has on patients.