Alcami Corporation · 19 hours ago
Quality Systems Sr. Manager
Charleston County, SC
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expAlcami Corporation is a company that delivers reliable solutions for transformative medicines. The Quality Systems Sr. Manager is responsible for ensuring compliance with quality standards and regulatory requirements, overseeing investigations and quality systems, and developing necessary quality documentation.
Pharmaceuticals
Responsibilities
Ensures GMP compliance with regulatory requirements and Company procedures. Specifically, 21 CFR parts 4, 210 and 211
Performs quality review and approval of complex documents, all types of data, audit responses, investigations, change controls, protocols, and/or reports
Collaborates with site Operations and Technical leadership to ensure timely closure of deviations, non-conformance investigations, corrective actions, and other Quality documents
Supports for client and regulatory agency audits and inspections to ensure minimal observations
Assists in driving on-time site responses to regulatory and client audit reports
Support through review and approval Quality system documentation
May perform analysis and trending
Coordinates, generates and maintains Quality Council / Management Review
Guides, instructs, and coaches team members in quality and compliance issues
Assists with quality improvement initiatives as needed
Develops quality SOPs or other quality documents and/or reports as needed
Supports the development and implementation of systems to aid in efficiency and compliance improvements for the site
Provides consultation on complex quality and compliance topics in areas of expertise
Develops and provides training in quality and compliance topics in areas of expertise
Provides Quality oversite for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc
Effectively performs a variety of complex duties, on schedule, with accuracy and competency
Maintains accurate files and records
Ensures timely completion and compliance with cGMP and all other relevant company training requirements
Other duties as assigned
Qualification
Required
Bachelor's degree in Chemistry, Biology, or relevant field and 10+ years of related experience required, or Master's degree in relevant field and 8+ years of related experience
Relevant GMP experience required
Expert knowledge of pharmaceutical regulatory requirements and cGMP required
Knowledge of quality systems and processes, change control, CAPA and data integrity required
Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s)
Excellent skills in leadership, coaching and influencing others, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required
Strong business acumen
Strong understanding of company SOPs, and regulatory guidance documents
Strong knowledge of safety procedures and quality compliance for assigned area
Strong knowledge of cGMP requirements
Strong experience with client audits
Excellent analytical and problem-solving skill, with the ability to think strategically
Strong attention to detail as well as time and resource management
Good presentation skills
Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction
Comply with the general policy of the company
High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction
Communicate well orally both for internal customers and team members as well as external customers
Ability to write reports and business correspondences
Ability to listen and respond well to external customers, partners, and colleagues at all levels
Highly goal and result oriented
Prioritizes tasks according to business objectives and can pursue several objectives simultaneously
Preferred
Experience in Environmental monitoring and critical utilities preferred for sterile operations
Knowledge of auditing preferred
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase