Operations Quality Manager

Are you a Operational Quality Manager looking for a challenging opportunity to drive Quality Operations improvement and simplification for your local region while working with Quality Managers across the globe? If so, this could be a great position to explore.

As an Operational Quality Manager, you will be responsible for Quality Assurance oversight of Operations in your local region to meet both regulatory and customer expectations. This includes harmonizing the quality standards and simplifying processes while driving both compliance and efficiency.

This Operational Quality Manager role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Accountable for the evaluation of manufacturing operational practices to ensure compliance with regulatory requirements.
• Lead, develop, implement and influence changes to meet requirements.
• Ensure all validation, quality, safety and environmental procedures and regulations are met, maintained and documented appropriately.
• Accountable for leading and developing the QA Operations Team.
• Accountable for review and approval of all cCMP documentation generated by all overseen functions.
• Accountable for the accuracy and completeness of all master batch records and all production batch records.
• Accountable for quality unit business processes and ensuring that they are standardly and correctly used by all overseen functions.
• Accountable for frequently and routinely measuring and communicating the performance and effectiveness of QA Operations.
• Represent the site directly with domestic and foreign regulatory inspectors regarding Operation Quality.
• Schedule Operational Quality support, as required, to support 3 shifts of operation.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

Why you?

Operational Quality Manager Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science
• Minimum of 7 years industrial experience in pharmaceutical or vaccine manufacturing; either in operations or quality assurance functions.
• 5 years prior experience managing quality assurance (Quality Systems, compliance, product release) within clinical or commercial organization OR 5 years prior experience supervising biologics manufacturing to include delegating, training, communicating and prioritizing site objectives, evaluating, coaching and discipling others.
• 5 years of Prior experience with licensed biopharmaceutical or biological products.

Operational Quality Manager Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Must be able to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
• Champion change and innovation, drive execution and results, motivate others and foster collaboration at all levels of the site.
• The ability to drive site objectives and results; work in a fluid environment; drive culture & lead department initiatives.
• Demonstrated interpersonal and leadership skills.
• The ability to function and influence within team-based organization.

Job Type: Full-time

Pay: $140,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Commute:

• Marietta, PA 17547 (Preferred)

Ability to Relocate:

• Marietta, PA 17547: Relocate before starting work (Required)

Work Location: In person