Sr. Manager, CMC and Regulatory Affairs
San Diego, CA
Secura Bio is a newly established pharmaceutical company with an approved oncology therapeutic sold in the United States and in eighteen other countries.
The Sr. Manager, CMC and Regulatory Affairs will be a key contributor to Secura Bio’s supply and regulatory compliance programs, to implement and maintain adequate systems for drug supply and regulatory submissions to FDA and other regulatory agencies. Responsibilities include contract manufacturing oversight, drug supply scheduling, documentation creation and review, regulatory documents preparation and review. The position will report to the Senior Director, Manufacturing, Regulatory & Quality.
Key Responsibilities Include:
- Select, negotiate and manage contract manufacturing organizations involved in drug substance and product manufacturing, packaging and testing.
- Prepare demand-supply programs and translate into manufacturing and packaging schedules, in collaboration with commercial and clinical groups.
- Management and oversight of distribution, shipping and import/export processes for product made in US and abroad.
- Monitor serialization processes and vendors in relation to DSCSA and FMD regulations.
- Participate of vendor audits in accordance with written procedures in accordance with vendor qualification program.
- Follow US and European regulations for GMP, identifying changes and updates to be applied to the company’s systems and processes.
- Actively collaborate with regulatory submissions, interacting with vendors and partners as needed.
- Interact and communicate with partners to ensure activities are conducted successfully and according to timelines.
- Conduct investigations as part of product complaints and CAPA program.
- Collaborate with internal departments to ensure effective regulatory and customer audit responses/corrective actions are generated in a timely manner.
- Establish plans and timelines, follow up on action items and identify solutions to typical situation in the supply chain of GMP pharmaceutical products.
- Participate of and support activities of the company’s quality system related to drug supply.
- Lead efforts and provide guidance to colleagues in the generation and revision of GMP documentation (e.g., procedures, specifications, etc.)
- Bachelor’s degree in a Life Sciences discipline or equivalent experience required.
- Minimum five (5) years of relevant experience in supply chain, manufacturing or equivalent CMC activities.
- Minimum of three (3) year of functional leadership experience.
- Thorough knowledge of cGMP regulations and good documentation practices.
- Thorough understanding of Regulatory Affairs and CMC operations.
- Detail oriented with strong written and verbal communication skills.
- Proven ability to lead and manage projects and teams.
- Experience interacting with suppliers, regulators and senior staff.
- Strong organizational and analytical skills.
- Must have excellent customer service attitude.
- Ability to develop, recommend and implement procedures.
- Aptitude and motivation to learn and assume new responsibilities.
- Experience with Electronic Documentation Management Systems (EDMS) is a plus.
- Prior experience with pharmaceutical contract manufacturing.
- Experience working in a start-up environment.
- Strong MS Office and presentation skills.
- Supervisory experience a plus.
Secura Bio offers competitive salaries and generous benefits.
If you meet the requirements for this position, please email us at firstname.lastname@example.org.