Pharma QA Manager: Lead Quality & Compliance

Alkermes; Wilmington (DE); On-site; USD 120,000 - 170,000; Full time

Job summary

Alkermes in Wilmington, Delaware, is seeking an experienced QA leader to manage day-to-day quality operations across QA and adjacent areas. You will develop and implement tactical initiatives directed by senior management and communicate events to Management when thresholds are outside the area of responsibility.

The role requires a Bachelor's degree in a scientific discipline and at least 8 years in pharmaceutical QA, preferably with parenteral dosage forms.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• Minimum of 8 years’ experience in a Quality Assurance role in the pharmaceutical industry, preferably with parenteral dosage forms.

Responsibilities

• Approve or reject master production records and SOPs.
• Approve or reject intermediate, bulk and finished products as seen fit.
• Participates in management processes for quality and compliance.
• Ensure that all necessary testing is carried out.
• Ensure initial and continuing training of direct reports is carried out and adapted as needed.
• Monitor investigations and factors impacting product quality.

Skills

GMP Knowledge

Quality Systems

GMP Compliance

Technology Transfer

Facilities Qualification

Regulatory Knowledge

Communication Skills

Site Knowledge

Regulatory Process Understanding

Education

Bachelor’s degree in scientific discipline

Job description

Alkermes in Wilmington, Delaware, is seeking an experienced QA leader to manage day-to-day quality operations across QA and adjacent areas. You will develop and implement tactical initiatives directed by senior management and communicate events to Management when thresholds are outside the area of responsibility.

The role requires a Bachelor's degree in a scientific discipline and at least 8 years in pharmaceutical QA, preferably with parenteral dosage forms.