Serán is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to disposition of raw materials and drug products. Required attributes include a results-driven and broad-minded quality assurance professional with extensive experience in compliance and regulations, quality systems management, investigations, training and mentoring, client relations, performance management, and change management. Extensive experience with direct or quality oversite of manufacturing operations is required.
The successful candidate will have excellent problem-solving skills and will identify critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments.Supervisory Responsibilities
- Leads and mentors Quality Assurance personnel.
- Recruits, interviews, hires and trains new staff.
- Oversees daily workflow of the department.
Responsibilities
- Leads and implements continuous improvement initiatives to reduce risk and improve efficiency for the company’s quality systems and department operations
- Management and scheduling of department operations
- Oversees and conducts review and approval of Investigations, CAPAs, Complaints, and Change Management
- Review and approval of SOPs, batch records, raw material records, and certificates of conformance/compliance
- Responsible for Quality oversight of activities involving raw material, drug product manufacturing, packaging, labeling, and warehouse activities
- Assures cGMP compliance systems and processes are in place to support raw material and drug product review, release, storage, and shipping
- Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate
- Supports internal audits, client audits and regulatory inspections
Required Skills and Experience
- Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase manufacturing operations
- In-depth understanding and application of cGMP principles, concepts, practices, and standards
- Experience with regulatory inspections by the FDA and EU authorities
- Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
- Demonstrated ability to partner with other functional groups to achieve business objectives
- Experience organizing and managing group responsibilities while working independently with minimal oversight
- Time and project management skills with the ability to multi-task and meet deadlines
- Excellent verbal and written communication skills
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
- Excellent organizational skills and attention to detail
- Strong analytical and problem-solving skills
- Strong supervisory and leadership skills
Education and Experience
- Minimum of a bachelor’s degree, preferably in a scientific discipline. An advanced degree is preferred
- 10+ years previous GMP and Quality experience in the Pharmaceutical industry with quality oversite of Oral Solid Dose manufacturing
- Experience with regulatory inspections by the FDA and EU authorities
Skills Required
- Minimum of a bachelor’s degree in a scientific discipline
- Advanced degree
- 10+ years GMP and Quality experience in the pharmaceutical industry with quality oversight of oral solid dose manufacturing
- Expert knowledge of GMP and cGMP guidelines and quality expectations for preclinical and clinical phase manufacturing
- Direct QA oversight of manufacturing operations, packaging, labeling, and warehouse activities
- Experience with regulatory inspections by FDA and EU authorities
- Experience reviewing and approving investigations, CAPAs, complaints, and change management
- Experience reviewing and approving SOPs, batch records, raw material records, and certificates of conformance/compliance
- Proven supervisory, leadership, mentoring, and people management experience
- Strong analytical, problem-solving, communication, time and project management skills
- Ability to support internal audits, client audits, and regulatory inspections
What We Do
Serán Bioscience is a contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical support for small and large molecule drug development. They offer services ranging from discovery to clinical manufacturing, including formulation design, spray drying, and analytical quality control, with a science-first approach aimed at helping clients advance medicines to the clinic efficiently.
