Charleston, South carolina
Pharmaceutical Compliance Lead Job Opening in Charleston, South carolina - 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.
Position Overview:
The Pharmaceutical Compliance Lead performs activities to ensure quality and compliance with applicable internal and regulatory requirements. These activities may include conducting internal audits, hosting customer audits and health authority inspections, evaluating vendors and maintaining quality metrics for these systems as part of the Quality Management System. Depending on experience, may serve as the lead auditor for external audits as well.
This role may also support the Regulatory Affairs team, as necessary, in filing assorted regulatory documentation and may be required to interact with US and international regulatory authorities. This position will be located in Charleston, SC .
As the Pharmaceutical Compliance Lead you will:
Perform internal audits at home site and other sites, as needed.
Host client audits and health authority inspections. Facilitate multidisciplinary responses to observations from auditing and inspecting bodies. Facilitate the completion of client questionnaires.
Facilitate the implementation of Confidentiality Agreements and Quality Technical Agreements (if needed), as part of the client auditing process.
Support the supplier quality/vendor management program for the site, including performing external quality assessments and/or audits. May serve as Lead Auditor for external audits.
Develop, analyze, and present quality metrics associated with designated areas of responsibility.
Collaborate closely with site QA Head, ensures compliance to FDA regulations, corporate policies, and site procedures.
Ability to facilitate training, investigations and internal audits for components associated with data integrity (paper and electronic records). Role holder must be able to determine gaps and develop the necessary plans to remediate identified issues.
Provide and receive training. Assist with development of Policies, SOPs or other quality documents with an emphasis on across-site collaboration, as needed.
Perform job responsibilities independently with limited supervision.
Effectively perform duties, on schedule, with accuracy and competency.
Maintains accurate files and records.
Perform other duties as assigned.
Minimum Qualifications:
Bachelor?s degree in Chemistry, Biology, or related scientific field with minimum of 7+ years GMP-related experience or Master?s degree in related field with 5+ years related experience. Certifications in auditing are preferred but not required.
Demonstrated knowledge of domestic and international cGMPs, compliance issues, inspectional trends, industry quality assurance practices, and quality systems
Proven experience supporting internal audits and/or regulatory inspections (strongly preferred)
Experience with computer as well as data lifecycle management
Proven ability to exercise strong business judgment with a solid understanding of the fundamentals of the pharmaceutical industry
Demonstrated cross cultural agility and resourcefulness
Ability to solve practical problems and deal with a variety of complex situations in a timely fashion.
Strong oral and written communication skills with the ability to work with people at all levels of the organization
Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) as well as networking tools to conduct and host meetings across sites.
Ability to travel domestically and internationally up to 10%.
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
Job Type: Full-time
Required education:
Bachelor's
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