Share Email Opening Title Head of Quality Assurance - San Diego  Category Quality Assurance   Description Why Join Recro: Mission and Culture: Our leadership proactively works to create and foster a culture that exemplifies our core values and mission. We strive to provide a work environment that is diverse, inclusive, challenging, and supportive. We are committed to continuous improvement both as individuals and as an organization and encourage our employees to continue their personal and professional development in a variety of ways. We strongly believe that every employee plays a crucial role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands on developing, producing or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives. Benefits: We offer a competitive total rewards package that includes health benefits, annual performance bonus, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions and much more! Your New Role: We are looking for a strategic leader to join our San Diego site as Head of Quality Assurance. As the Quality Assurance (QA) Head you will provide guidance and direction to the QA teams at the San Diego site, leading all Quality Systems. You will be responsible for ensuring that regulations are effectively established and maintained to provide scalability, keeping the San Diego site in full compliance with U.S. pharmaceutical development and manufacturing requirements and applicable global regulations by working closely with key business partners in Operations, Regulatory Affairs, and other functional groups, as necessary.  How You Will Make An Impact: Develop, implement and monitor quality systems that are compliant with company, client and regulatory requirements while encouraging others to think outside of the box to come up with creative and cost-effective solutions to proactively. Establish and oversee the San Diego Quality Affairs Committee to ensure that all issues have complete review and follow-up. Develop QA group goals that support site and company-wide goals and assist staff in prioritizing, coordinating and implementing these goals. Continually evaluate strategic goals and develop and oversee programs with broad impact on site Quality Assurance. Develop and review quality related metrics and KPIs to measure progress against Quality Objectives. Ensuring that they are used to improve the processes, efficiency and quality of the product and/or systems. Responsible for writing, approving, negotiating quality agreements with customers, vendors and suppliers that align with site and regulatory requirements while maintaining customer satisfaction. Oversight of the change control process and where necessary, review and approve change controls and documents. Coordinate the approval and/or notification of changes with the customers as outlined by the quality agreements. Ensure management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine impact of change. Develop and manage the departmental budgets. Provide 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. Responsible for oversight of Regulatory Agency (US and Rest of World) 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. Partner with Business Development personnel in assessment of quality requirements for prospective new clients. Partner 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. Support development, operation, and evaluation of GMP training/re-training programs. As A Leader You Will: Hire, train, develop, mentor and manage the QA team at the Recro San Diego facility. Oversee, participate in and approve the interviewing, hiring and training of department employees. Conduct performance evaluations for direct reports; and assists direct reports with performance evaluation process for their units.   Position Requirements Ideal Candidate Will Bring: Bachelor’s degree in chemistry, math or related scientific field is generally required; advanced degree (Masters, PhD) is an asset Generally, 10 years of relevant work experience in pharmaceutical quality oversight roles supporting manufacturing processes is required. Generally, 7 years of people management experience. Established subject matter expertise in US cGMPs and Pharmaceutical Quality requirements, as well as applicable global regulatory requirements. Experience should span across a variety of pharmaceutical dosing applications and pre-clinical development through commercial phases. Experience as the Quality lead during multiple types of inspection processes with a thorough understanding of inspection techniques. Strong ability to move between tactical and strategic aspects of the business. Proven ability to set direction, build strong cross functional relationships. Ability to effectively communicate highly complex results and requirements to all levels, internal and external. Strong business acumen, financial management, project management, analytical and presentation skills. Ability to drive and appropriately prioritize requirements and activities.   About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. New hires will pass a background check and drug screen as a condition of employment.   EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   EmpID None Specified  This position is currently not accepting applications. To search for an open position, please go to http://Societal.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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