Quality Manager - Aseptic Manufacturing - United States
What differentiates us at Alcami? Our people.
Help shape the future of medicine and join us – we are a pharmaceutical contract development manufacturing organization (CDMO).
Alcami Corporation is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies. We offer a range of services from four distinct pillars: Development Services, Analytical Testing, Drug Product, and APIs. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With six locations in the U.S. and a global location in The Netherlands, the Alcami family is growing rapidly. Picture yourself at Alcami and apply today.
The Quality Manager will manage the day to day Quality tasks and responsibilities of the Quality department. Representing all aspects of QA when interfacing with clients. The Quality Manager functions as a subject matter expert for when interacting with regulatory agencies, handling quality issues, audits and inspections. This position is located at the Charleston, SC facility.
As the Quality Manager, you will:
- Provide QA leadership and influence other functional departments to ensure that internal operations achieve and maintain compliance with Alcami quality standards
- Provides oversight of the Quality Management Systems (QMS)
- Acts as Chair of the Quality Council
- Has final approval of GMP documents / Investigations / CAPA, etc.
- Final disposition (Release and Rejection) of raw materials, intermediates, APIs and finished drug products and/or biologics
- Directs the Internal Audit function, External Audits (Client and Regulatory)
- Schedules, implements plans for annual audit reviews taking into consideration quality metrics, industry trends, and external regulatory environments
- Responsible for monitoring the timely completion of corrective action plans and to coordinate the reporting of quality metrics to site management during management reviews
- Supports Vendor Approval, Qualification, Materials Qualification
- Collaborates in the technical development, review, and approval of GMP manufacturing production batch records, and standard operating procedures (SOP)
- Maintains a high degree of personal, professional development through a combination of internal and external training and participation in professional associations as appropriate
- Manages for results by setting and communicating goals and metrics
- Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance development planning
- Supports additional QA activities such as Document Control/Archiving, Complaint Management, Quality Metrics, Annual Product Reviews
Qualifications for success:
- Bachelor degree in Chemistry, Biology, Microbiology or related field and a minimum of 5 years of experience within a regulated Pharmaceutical environment leading Quality teams within a regulated Pharmaceutical environment
- Demonstrated knowledge of pharmaceutical regulatory requirements such as 21CFR part 210, 211, etc.
- Working knowledge of cGMPs, FDA regulations and ICH guidelines
- Proven ability to effectively lead a team and work independently, as a team leader or member
- Proficient use of Microsoft Office Suite
- Ability to travel domestically up to 10%
- Validation, Qualification, Installation/Operation/Performance(IQ/OQ/PQ), URS approval
- Previous experience acting as an internal or external auditor
- Previous experience working in an Aseptic Manufacturing Environment
- Interaction with regulatory authorities, either front room or backroom
- CQA certification
What we offer you:
- In Wilmington, an onsite Learning Center for working parents
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- A menu of voluntary benefits including short & long-term disability, life, accident, critical illness and hospital indemnity insurances
- Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
- To complement your personal financial strategy, we also have 401(k) matching