Quality Systems Sr. Manager

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

 

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Job Summary

The Quality Systems Sr. Manager is accountable for driving results in a fast paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures.

Responsibilities include the technical oversight of investigations and Quality Systems. This position will be performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the manufacturing facility.

Activities include reviewing documents and data, investigation review/approval, CAPAs, Change Control, supporting audits and inspections, consulting on quality and compliance issues, and performing trend analysis where needed, and performing quality and compliance training as needed. The Quality Systems Sr. Manager  develops SOPs or other quality documents as needed.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:30pm.

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.

Qualifications

• 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
• Experience in Environmental monitoring and critical utilities preferred for sterile operations.

Knowledge, Skills, and Abilities

• 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).
• Knowledge of auditing preferred.
• 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 c