Job Title: Project Management Senior Associate
Location:  Remote
Duration:  1 year (Possible Extension)

Fully Remote - PST preferred

Ideal candidate - 3-5 YOE, lifecycle management knowledge of full product manufacturing stages experience.

The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for Customer Facing SKU control. This role will own the execution of the implementation plan in terms of project management and change control execution. This role will apply project management and operational excellence to support the execution of product launches, variation implementations, and other activities related to the lifecycle management of client products.

SPECIFIC RESPONSABILITIES INCLUDE BUT ARE NOT LIMITED TO:

•Manage change control timelines with input from Variation Leads and/or Regional Operations Leads driving task completion across multiple functional areas

•Assure timely and fully compliant (RFT) maintenance of Change Control Management system related to Global Distribution Change Records (GDCR) and/or Customer Facing SKU Change Records (CFSCR)

•Provide timely updates to stakeholders, e.g., Regulatory, Supply Chain, Manufacturing, Quality on status of GDCR and/or CFSCR readiness activities and related projects

• Represent the SCPM Hub in Project Planning meetings, Variation Execution Meetings and/or Regional Operations Team meetings

•Establish effective relationships with key stakeholders across multiple functional areas

• Identify and analyze complex problems and opportunities to streamline departmental activities and lead projects to drive improvements

•Create new procedures and processes to drive desired results

•Partner with all relevant stakeholders to share and implement best practices

•Proactively navigate a challenging and dynamic environment, with rapidly changing priorities

• Execute specific projects and business cases as required

•Works under minimal direction

 

Day to Day Responsibilities:

Train and gain access to systems required quickly. Work independently, absorbing knowledge and experience through participating in various strategy and execution forums/meetings for all products, following SOPs, and learning from Supply Chain PMs, translating requirements into Change Control records = Customer Facing Sku Record (CFSCR) or Global Distribution Change Record (GDCR) that meets required regulations, compliance, and GMP standards. Ensure timeliness of activities by partnering with Assessors and Task owners to ensure their activities are completed on time, supporting Launch or Variations of client products.

 

Top 3 Must Have skills:

1) Change Control experience in Life Cycle Management, with Trackwise other Quality System experience
2) Knowledge of GMPs and Biotech/Pharmaceutical Industry
3) Supply Chain and/or Quality background/experience, especially in Lifecycle Management

Below certifications a plus:
ASCM/APICS and/or PMP certification a plus.

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

 

Possible Extension: Yes

Red Flags:

Lack of strong communication skills...this role partners with key client staff from all Regions, Sites, and Corporate functions, globally. Clear, concise, communication is required to ensure strategies are understood and translated into Change Control documentation, which are then executed upon by many parties globally, to reach the end goal, shipping product to patients.
Unable to manage/execute multiple project concurrently.
Lack of analytical skills, science-based, pulling information from multiple sources
Lacks flexibility to support PST or EST time zones

 

Interview Process: Video Call Interview

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $45.72/hr.