Regulatory Compliance Project Manager 525709
Regulatory Compliance Project Manager 525709
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$ 105000 - 131000
1 Vacancy
Job Description
Would you like to join an international team working to improve the future of healthcare Do you want to enhance the lives of millions of people Grifols is a global healthcare company that since 1909 has been working to improve the health and wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.
Summary:
Responsible for managing various facets of quality projects related to submissions to the FDA review and approval of Validation documents and the management of Methods Validation.
Essetinal Job Functions:
Develop quality objectives manage and maintain project plans
Interface with various groups to ensure that objectives and timelines are met specifically for preparing complex technical submissions related to major facility projects
Review and approve validation protocols and final reports
Ensure implementation and maintain compliance of Methods Validation
Write and revise documents and procedures
Plan direct and manage internal and contract manufacturing projects from concept to production using recognized project management tools including initiation control and closure.
Formulate project objectives approaches schedules risk assessments budgetary constraints and manpower requirements in accordance with customer needs.
Lead crossfunctional project team on project to meet objectives ontime delivery and budget constraints
Establish and maintain timely and clear communication with project team customers and suppliers. Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities.
Provide regular status update to senior management.
Required Experience /Skills & Educational Qualifications
Bachelors degree in the sciences or related field.
Supplemental training / education in business administration desirable.
Project management certification (PMI) a plus.
Minimum 5 years experience in pharmaceutical medical device plastic/parts design industry including 3 years in increasingly complex project management duties in a GMP product development / process improvement environment.
Working knowledge of QS cGMP Process Flows Design Software Schematics.
Must have sound knowledge of MS Office MS Project relational database.
Strong interpersonal skills and ability to communicate with all levels of the organization.
Ability to organize prioritize and manage multiple responsibilities with low level of supervision.
Detail oriented with strong emphasis on accuracy and thoroughness.
Knowledge of 2D/3D barcoding and electronic data transfer systems highly desirable.
Willing to travel domestically and internationally up to 20.
The estimated pay scale for the Regulatory Compliance Project Manager role based in Los AngelesCA is$105000 $131000 per year. Additionally the position is eligible to participate in up to 8 of the company bonus pool. We offer a wide variety of benefits including but not limited to: Medical Dental Vision PTO up to 5 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education experience skillset knowledge where the role is performed internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909 Grifols has been a family company that prides itself on its familylike culture. Our company has more than tripled over the last 10 years and you can grow with us!
*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants including those with arrests or conviction records in a manner consistent with the requirements of applicable state and local laws including the California Fair Chance Act the Los Angeles County Fair Chance Ordinance for Employers and City of Los Angeles Fair Chance Initiative for Hiring Ordinance.
Location:NORTH AMERICA : USA : CALos Angeles:USVALLEY Valley Bl Mfg Plant LA CA
Required Experience:
IC
Employment Type
Full-Time
