VP Quality

Why Join Bend Bioscience?

Mission and Culture:

At Bend Bioscience, we Advance Health Through Innovation by developing and manufacturing therapies that improve patients' quality of life. We believe every employee plays a vital role in our mission to advance human health through innovative client partnerships. Whether you’re involved in development, manufacturing, testing, or contributing your expertise in other areas, your work will have a meaningful, positive impact on countless lives.

Do you:

• Love finding new and better ways to do things?
• Want to help develop medicines that improve patients' lives?
• Have a passion for learning and growth?
• Nerd out on science and technology?
• Value collaboration and teamwork?
• Embrace audacity and entrepreneurial thinking?
• Prioritize safety and lead by example?
• Care deeply about doing the right thing?

At Bend Bioscience, we foster a diverse, inclusive, challenging, and supportive culture. We are committed to continuous improvement, both as individuals and as an organization, and we encourage personal and professional development at every level. Join us to make a real difference in patients’ lives through your work.

Your New Role At Bend Bioscience:

In this role, you will be a business partner who uses industry-specific knowledge to foster buy-in and participation across business locations, ensuring effective governance, assurance and improvement of the processes required to comply with the complex array of U.S. pharmaceutical and applicable global regulations that govern our operations.

Essential Functions (other duties may be assigned):

• Responsible for development, implementation, and ongoing monitoring of key quality systems that operate in accordance with corporate and business unit quality policies and regulatory agencies. Evaluates the impact and effectiveness of changes to the quality systems and encourages others to identify improvements.
• Lead, assess, mentor, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
• Key contributor to long term strategic planning and part of senior leadership team.
• Work with internal and client teams to establish Quality strategy, define roles, and problem solve.
• Oversee the Quality Affairs Committee to ensure that all issues have complete review and follow-up.
• Oversight of Regulatory Agency (US and International) inspections, as well as customer, and internal audits of the facility. Directs the preparation of audit reports and responses to observations, ensuring that recommended conclusions and actions are appropriate and achievable.
• Ensure that potential compliance issues at the site are elevated to executive management and that any communication with required parties (regulatory, customer) is completed in accordance with established protocol and timelines.
• Partners with Business Development personnel in assessment of quality requirements for prospective new clients. Partners with other functional leads in onboarding of new client requirements within established quality systems/programs. Leads assessment of new quality systems/programs to meet new client needs either directly or by delegation.
• Responsible for developing and reviewing quality related metrics and ensuring that they are used to improve the processes, efficiency and quality of the product and/or systems. Ensure key performance indicators measure progress against Quality objectives. Monitor, communicate and act on any emerging trends. Oversee the preparation of monthly / quarterly reports for senior and site management.
• Responsible for writing / approving / negotiating quality agreements with customers. Ensure agreements do not contradict regulatory or site requirements while maintaining customer satisfaction. Responsible for the management of the quality agreement process for vendors / suppliers.
• Responsible for developing and managing the departmental budgets across the locations.
• Provides strategic level direction to key staff to complete activities related to monitoring, annual product review, release, documentation, validation, auditing, and quality control.
• Ensure that deviations and investigations are resolved timely and effectively; that recommended changes/corrective actions/preventative actions are evaluated, initiated, and driven to completion; and that the improvements are evaluated by assigned cross-functional teams to ensure that they are effective and embraced by the impacted group(s).
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies Bend Bioscience’s cultural values and aligns daily actions with department and company culture.

Education & Experience

• Generally, requires a minimum of fourteen (14) years of experience in Quality with a Bachelors in related field.
• Generally, requires a minimum of ten (10) years of experience leading and managing teams.

Knowledge, Skills, and Abilities

• Established subject matter expertise in US cGMPs and Pharmaceutical Quality requirements, as well as applicable global regulatory requirements.
• Experience or knowledge of statistical analysis is highly preferred.
• Thorough understanding of US FDA and international regulatory bodies’ inspection techniques, including experience as the Quality lead during multiple types of inspection and audit processes.
• Interpersonal relationship skills to develop and mentor a department and interact with other professionals and management in the organization.
• Advanced knowledge of computers with proficiency in using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry such as resource planning, documentation

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)