This position will require a sterile quality background for understanding of a biological product, combination product knowledge is preferred. In addition, in depth knowledge of Quality Systems including change control, batch record review, stability programs, product specifications and certificates of analysis. This person will interact with internal and external business partners, contract manufacturers and contract laboratories.
In this position, the QA Manager will have oversight and hands-on management of:
- Working directly with the worldwide quality and regulatory teams to provide manufacturing updates, facilitating documentation requests with Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTL), and liaison for change control review and approvals.
- Creating product specifications for new ROW (rest of world) markets for product
- Ensuring new market stability requirements are added to the stability program.
- Update internal standards and marketing assessments for new ROW markets.
- Create and/or review Certificates of Analysis for ROW markets.
- Upload batch documentation for support of ROW batch releases
Primary responsibilities of this role include, but are not limited to, the following:
- Creating and/or updating of documentation for new ROW markets
- Creation of new market specifications, which includes the Certificate of Analysis template and updates to the internal standard and market assessment.
- Work directly with the ROW Quality and Regulatory team regarding documentation requirements for new submissions
- Create and/or update any stability documentation to ensure the program captures ROW market needs. Assist with writing reports for the ROW markets.
- Assisting the Team with documentation for new or updated dossiers:
- Work with the CMOs and CTLs to obtain needed requirements for dossier submissions.
- Track all documentation in an organized manner.
- Assist with change controls for ROW markets:
- Understanding of change controls: major product updates such as technical transfers and scale up processes, test method updates, etc.
- Provide necessary documentation for the regulatory updates.
- File, retrieve, and maintain organized records
- Communicate with external business partners / CMOs regarding quality related issues when necessary.
- Review Annual Product Reports / Product Quality Reports when necessary.
- Create and/or update SOPs for process improvements.
- Ensure training and metrics are performed on time.
- Keeps abreast of industry regulations and cGMP trends. Stays informed of FDA and ICH Guidelines related to GMP (Commercial & Development) and ROW requirements.
- BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 10 years’ experience in the Pharmaceutical Industry working with sterile and medical device products. Must have a minimum of five years in a quality organization. Other degrees will be considered based on extensive industry experience.
- Strong experience in documentation understanding: protocols, reports, raw data, specifications, and batch records.
- Has knowledge of 21 CFR 210/211, 21 CFR Part 4, EU-GMP, EU-MDR, ICH Q7, ICH Q10, ISO 13485.
- Must display strong organizational skills with the ability to lead team meetings and to manage multiple projects at one time.
- Must hold strong interpersonal and communication skills. Must have the ability to work well with diverse groups including the ability to work in a team environment. Strong technical writing and computer skills also required.
- Must display the ability to work independently with little or no supervision and plan and accomplish set goals