QA Manager - Holly Springs, NC
QA Manager - Holly Springs, NC
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$ 149352 - 149352
1 Vacancy
Job Description
Lets do this! Lets change the world!
In this dynamic role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing including development clinical launch and commercial operations. The Manager Quality Assurance will hire train develop and manage Quality Assurance professionals to successfully deliver on role to support (Good Manufacturing Practices) GMP Manufacturing and to oversee and manage change in an effective efficient and compliant manner. This includes partnership with Manufacturing Facilities & Engineering and other support functions providing coaching guidance and direction in regards to deviations quality systems and compliance aspects.
The initial focus of this role will be on the ANC startup to prepare the new facility for Operational Readiness.
Candidate will be working on site. After the facility startup phase the successful incumbent will be expected to transition to a shift working schedule to include late afternoon and nights.
Oversee ANC startup activities for facilities utilities equipment systems and processes with alignment and integration into the Amgen Quality Systems including: Interview candidates to build the ANC PQA team Author/review/approve quality documents related to: Standard Operating Procedures (SOPs) user requirements risk assessments training materials engineering documents automation documents commissioning test protocols/reports environmental & utility qualification protocols/reports validation protocols/reports Oversee execution of and change management related to the following: factory acceptance commissioning tests facility qualifications and validation activities.
Manage a team of PQA staff and their daily operations (verify training schedules ongoing tasks prioritization and support needed)
Oversee staff/team performance
Prioritize and support staff development
Provide on-going Quality oversight to ensure products are manufactured tested stored and
distributed according to current Good Manufacturing Practices (cGMP) Good Documentation
Practices (GDP) and other applicable regulations
Participate in Inspection Readiness program activities to ensure facilities equipment materials organization processes and procedures comply with cGMP practices and other applicable regulations
Develop or contribute to the development of procedures and standards by which others will
operate
Develop and communicate goals and objectives to staff and key partners
Monitor goal performance and coordinate action for improvement of team and overall Plant
Quality Assurance (PQA) performance by championing department operational excellence and Lean efforts.
Assist project teams in establishing priorities project timelines and in securing resources
Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership
Partner with internal personnel at various management levels to resolve issues establish direction obtain resources and drive change
Review and approve operational and product manufacturing procedures process validation protocols and reports for manufacturing processes environmental characterization reports and change control documents.
Support site audits and inspections.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of Quality experience OR
Associates degree and 10 years of Quality experience OR
Bachelors degree and 5 years of Quality experience OR
Masters degree and 3 years of Quality experience OR
Doctorate degree
Preferred Qualifications:
Previous managerial experience directly managing people and/or experience leading teams projects programs or directing the allocation of resources
Experience and training in CDOCS Trackwise Maximo LIMS MES Werum and other systems and applications
Experience in managing multiple competing priorities in a fast-paced environment
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate clearly facilitate discussions and present to audiences at all levels of the organization.
Ability to communicate and collaborate effectively with technical and senior management staff.
Experience and systems knowledge in areas of manufacturing investigations Corrective Actions/Preventative Actions (CAPA) product release validation and/or change control
Ability to develop meaningful team and staff goals manage performance and coach and develop staff
Ability to manage timelines and deliver results to meet or exceed department and company goals and objectives
Ability to solve complex problems and evaluate scientific data. Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs.
What you can expect from us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.
In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:
A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts
A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models including remote and hybrid work arrangements where possible
Salary Range
127757.00 USD - 149352.00 USD
Required Experience:
Manager
Employment Type
Full Time
