Recro offers competitive pay, bonus eligibility and stock option grants for this role!
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.
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 an Associate Director, Compliance. In this role you will lead a team responsible for assuring compliance to cGMPs. You will have the opportunity to manage the audit program, supplier quality agreements and annual product reviews.
As the Compliance leader you will ensure the effectiveness of CAPA change controls. You will provide quality oversight across the organization. You will run the day-to-day operations of these areas of QA oversight to ensure full compliance, ensuring site leadership is informed of all critical issues.
How You Will Make An Impact:
Provide direction and guidance to personnel responsible for assuring the completion of internal audit and monitoring programs of all cGMP departments, managing suppliers including external audits, risk assessments, quality agreements, and management/approval of all suppliers from laboratories, manufacturers, packagers and component manufacturers.
Chair the Vendor Review Board, be the primary QA representative for Material Review Board and participate in activities related to the Quality Affairs Committee (QAC). Participate in the QA Site Leadership Team.
Ensure management of changes associated with equipment and facilities is carried out using science and risk-based assessment to determine impact of change
Manage review of equipment, utilities, software, and facilities from a QA perspective with responsibility for approval or rejection of validation protocols and reports, procedures, calibrations, and investigations.
Monitoring status of ongoing quality activities and developing processes to ensure on-time completion of such activities.
Ensure Key Performance Indicators measure progress against Quality objectives. Monitor, communicate and act on any trends emerging. Prepare monthly reports as requested for QA management.
Play a key role in the oversight of operational activities ensuring the Quality principles are applied in all areas.
Provide new employee training and other cGMP training to the site as required.
Assist with customer/client audits and visits; Write audit report and respond to customer observations as required
Participate or assist with regulatory audits as required; write audit report and prepare responses as required.
As A Leader You Will:
Hire, train, develop, mentor and manage the Compliance team.
Ensure there is continual improvement of the Quality Systems on site.
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.
Ideal Candidate Will Bring:
Bachelor's degree in chemistry, math or related scientific field.
A minimum of 10 years' experience in pharmaceutical QA.
5 years' experience supervising and leading direct reports.
Experienced in current Good Manufacturing Practices and familiar with material release, process validation, change control and documentation practices
Thorough understanding of quality systems and the electronic reporting/tracking/trending systems such as Veeva, Maximo or similar systems; able to effectively assist in configuring these electronic systems as needed.
Knowledgeable in pharmaceutical regulations and ability to interface positively with regulatory agencies, customers, and company departments.
Must have strong management skills with the ability to select, coach, develop and engage direct reports.
Must be able to write investigations, technical reports, validation documentation, procedures, and prepare training programs.
Strong analytical skills, with an ability to use scientific knowledge and statistical methods to identify potential problems and trends.
Knowledge of pharmaceutical industry guidelines, trends and practices.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. Must be able to pass color/contrast testing passing 9 of 12 elements.
If you would like to apply for this position, please visit our website at www.recrocdmo.com and click on the "Careers" section.
New hires will pass a background check, drug screen and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.
We are an EOE dedicated to a diverse work force and 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.
Recro 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 Gainesville, Georgia and San Diego, California.