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.
Our sterile manufacturing facility is located in Charleston, SC, a vibrant city well-known for its coastal beauty, climate, cultural arts, and thriving business environment. Recently, Charleston received 1st place honors as the “Most Livable City in America” (US Conference of Mayors).
The Sr. Regulatory Compliance Specialist effectively performs activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. Assists with the development of SOPs or other quality documents as needed. Performs the role of Lead Inspector for external audits. Acts as consultant with clients for all level of regulatory issues. Provides guidance and mentoring for other Regulatory Compliance employees.
Those who support the Regulatory group will also be required to file various regulatory submissions, may be required to interact with US and international regulatory authorities and negotiate regulatory services with clients as needed.
As the Senior Regulatory Compliance Specialist, you will:
- Performs quality review and approval of documents, data, protocols, and/or reports.
- Performs internal and external quality audits and/or inspections.
- May serve as a Lead Inspector for external audits.
- Hosts client audits and inspections.
- May host regulatory inspections
- Maintain quality databases
- Assist with the implementation and supports quality systems, including but not limited to vendor management, training, internal audit program, and overall regulatory inspectional readiness initiatives.
- Assist with quality improvement initiatives as needed.
- Consult with clients on all levels of regulatory issues.
- Assist with development of SOPs or other quality documents as needed.
- Effectively performs duties, on schedule, with accuracy and competency.
- Maintain accurate files and records.
- Serve as an effective member of the Regulatory Compliance team and may serve as a mentor to other Regulatory Compliance employees in area of expertise.
- Performs other duties as assigned.
- Complies with company polices and SOPs.
- Works the hours necessary to meet scheduling commitments, is punctual with minimal absenteeism.
- Travel: Some domestic and international travel may be required.
Qualifications for success:
- Bachelor’s Degree minimally with Masters preferred. Bachelor’s degree in Chemistry, Biology, or related field with 10+ years GMP related experience, or Master’s degree in related field with 5+ years related experience, or equivalent educational and work experience.
- Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
- Good written and oral communication skills.
- Good math skills.
- Good computer skills and knowledge of Microsoft Office products.
- Ability to be trained and to mentor.
- Ability to act independently.
- Ability to interact well with clients and regulatory agents.
- Ability to interact well with employees at all levels.
- Ability to negotiate.
- Ability to lead audits.
- Ability to act as a consultant.
What we offer you:
- 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