The Quality Control Manager mRNA provides leadership, scientific, compliance and technical expertise for all QC activities at the mRNA lab within the Monza, Italy site.
These activities include the timely in
- testing of toxicological, clinical and commercial bio-pharmaceuticals, qualification/validation of analytical methods for support of cGMP Manufacturing and the translation of assay methods from clients and/or Assay Development to the cGMP QC testing laboratory.
**What will you do?
**
- Manages a team of Supervisors and professionals within Quality.
Hires and Develops employees within the department.
Assigns work, provides vital mentoring, and takes necessary disciplinary actions.
- Develops appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement.
- Serves as primary QC analytical contact for regulatory inspections and client audits.
- Provides oversight of method transfer (to or from internal or client sites), qualification, validation and/or verification.
- Ensures methods remain current and meet applicable regulatory and pharmacopoeia (USP, Eur.Ph., etc.)
requirements.
- Establish and maintain ICH compliant stability programs for clients.
- Coordinates raw material testing programs as applicable to the site.
- Supports establishment and/or improvement of operational metrics.
- Sponsors, leads, and/or supports establishment of electronic systems for the QC team.
- Subject matter expert responsible for ensuring GMP reports, including Deviations, Out-of-Specifications, CAPAs and Change controls are accurately investigated, implemented, executed and/or remain effective.
- Analyzes regulatory authorities' programs, guidance documents and activities in areas relevant to testing of biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
- Evaluates the functional strengths and developmental areas within the organization and focuses on continuous improvement.
**How will you get here?
**
- Minimum required education: Bachelor's degree in Life Sciences or Chemical/Biological Engineering
- Minimum of 8+ years of proven experience in a quality position within the biological and/or pharmaceutical industry (or combination of an advanced degree and quality experience; Master's Degree + 5 years or PhD + 2 years).
- At least 2 years of supervisory experience
- Experience with writing Deviations, Lab investigations, Root Cause Analysis and OOS required.
- Experience in method development and validation
- Experience in a QC GMP Laboratory, including documentation, reports, and exceptions
- Advanced skills in Electronic Sample management and quality systems
**Preferred Experience**:
- Experience with Gene Therapy / Plasmid DNA / mRNA products.
- Hands-on experience with methods development, SOP and test record development, laboratory equipment, and its calibration
- Experience in supporting functional areas (e.g.
PD, Manufacturing, QA, Engineering, EHS)
- Contributor to scientific and regulatory journals such as PDA, USP, Eur.
Ph
**Knowledge, Skills, Abilities**:
- Strong interpersonal and communications skills; written and oral.
Ability for technical writing a must.
- Ability to multitask, strategically and tactically
- Have a solid understanding and experience with cGMP FDA, EMEA and ICH regulatory requirements, as well as other regulatory experience such as regulatory inspections and CMC (IND/BLA, etc) preparation for biologics or pharmaceuticals.
- Should understand scientific aspects of modern laboratory, environmental monitoring and microbiology procedures, as well as experience in the handling and testing of aseptic biologics intermediates and final product
- Have leadership, delegation, and motivation skills to effect performance of individuals in the area of responsibility and throughout the organization.
- MS Word, MS Access, MS Excel, MS PowerPoint, MS Outlook, and MS Project experience.
- Highly motivated, organized, and detailed oriented.
Self-starter with the ability to work efficiently and independently and to solve problems.
Consistent record leading multiple projects and responsibilities simultaneously and prioritizing tasks in order of importance.