Regulatory Compliance, Project Manager

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 cross-functional project team on project execution to meet objectives, on-time 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

• Bachelor’s 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 Angeles, CA, is $105,000 - $131,000 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 family-like 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 : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA

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