- Responsible for managing the Site Quality Assurance Operational Unit, which includes serving as the main Customer Program QA Point of Contact, overseeing Deviation and CAPA Management, Batch Record Release & Review, and providing Shop Floor QA Oversight.
- As the head of QA Operations, you will lead, develop, and engage the Site QA Operations Team to ensure successful delivery of customer projects.
- Providing leadership for Quality Operations in alignment with directives from the Director of Quality Assurance and Control. This involves adhering to organizational policies, relevant laws, and industry guidance.
- Directing all operations related to release activities (QA) and driving continuous improvement. Additionally, ensuring inspection readiness across manufacturing and operational areas.
- As the Associate Director, you will be responsible for retaining, training, qualifying, validating, and timely deployment of adequate resources to ensure compliant material release according to site schedules.
- Maintaining cGMP (current Good Manufacturing Practices) throughout the product life cycle, in accordance with company quality and compliance policies, and relevant regulations and guidance.
- Responsible for aligning goals with the Director of Quality Assurance and Control. This involves achieving consistent results in line with the site strategy, fostering employee development, planning and managing work assignments, and driving continuous improvement. Additionally, addressing complaints and resolving issues.
- Actively participates in customer and government quality audits and inquiries from a quality operational perspective. This includes material production, deviation resolution, risk documentation, and release decisions.
- Represents the quality perspective within the site's leadership team.
- Holds a key role in the site's quality council.
- Ensures that functional site cGMP Inspection Readiness Programs are established throughout the product life cycle. Collaborates with business units to execute these programs across all functions within the site. Allocates necessary resources for successful program implementation.
- Change management, investigations, and CAPA (Corrective and Preventive Action) activities.
- Product field performance, including complaint management and product performance trending.
- Timely reporting of quality metrics and develops remediation plans where metrics fall short of targets.
- Continuous improvement initiatives related to operational impacts, adhering to quality and regulatory requirements.
- Accountable for the operational budget and financial performance of the site's Quality Operations Organization.
- The qualifications for this role include a Bachelor's Degree from a college or university, along with 10 years of related experience. Alternatively, an equivalent combination of education and experience would also be considered.
- Demonstrates strong leadership abilities and possesses an extensive understanding of the concepts outlined in the responsibilities.
- Proficient in governance and decision-making related to regulatory compliance. Has operational knowledge of API (Active Pharmaceutical Ingredient) manufacturing.
- Skilled at prioritizing workloads and resolving issues based on compliance requirements and scientifically documented risk assessments.
- Exhibits excellent customer service skills.
- Drives a successful customer experience while meeting business targets from a Quality perspective.
- Proficient in written communication.
- Demonstrates effective oral communication skills.
- Ability to use Microsoft Office Suite.
- Planning skills.
- Implementation and follow-up capabilities.
- To interact with colleagues across all levels of the organization.
- Possesses high analytical capabilities.
- Working with mathematical concepts such as probability and statistical inference.
- Concepts like fractions, percentages, ratios, and proportions to practical situations.
- Basic arithmetic operations (addition, subtraction, multiplication, division) using whole numbers, common fractions, and decimals.
- Compute rates, ratios, and percentages and interpret bar graphs.
- 401K
- Critical Illness Insurance
- Health, Dental and Vision Insurance PPO/HSA
- Wellness Program
- Vacation
- Life Insurance
- Tuition Reimbursement
- job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
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Head of Quality Assurance Operations - Longmont, United States - Fraser Dove International
Description
Associate Director, Site QA Operations
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
Fraser Dove International is partnering exclusively with a Biopharmaceutical CDMO. Operating In Colorado, they are committed to their ultimate goal of improving people's lives.
Our client is seeking a strategic leader to lead the site QA team.
Discover more about our Associate Director, Site QA Operations opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
What you will do:
As the Associate Director, Site QA Operations your duties and responsibilities will include:
What you will bring:
These are the skills and experience you will need to succeed as the Associate Director, Site QA Operations:
What you will get:
These are the perks and benefits that will complement your base salary:
Got what it takes?
To apply for the Associate Director, Site QA Operations click the 'Apply' button below or contact the Executive Search Consultant – Kaitlin Francis – on
Please Note:
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.
