Sr. Project Manager, Compliance and Documentation

Job Description Summary The GCS Compliance Senior Project Manager will support the GCS organization within the Medication Management Solutions (MMS) Business Unit by leading projects which will improve GCS compliance to quality and regulatory requirements.
In addition, you will collaborate with SMEs in GCS and other cross-functional teams to document GCS procedures in compliance with our internal QMS and help develop the strategy for field action remediation.
Specifically, this role will partner with the Senior Manager, to prioritize compliance related initiatives and lead projects which will result in improved compliance to quality and regulatory requirements.
This role will be responsible for leading GCS owned CAPAs, driving initiatives related to medical device up-classification, and identifying/leading continuous improvement opportunities.
Additionally, he/she will be responsible for leading GCS procedure creation and maintenance in compliance with all applicable quality requirements and providing GCS audit support.
The Senior Project Manager will have solid project management skills, attention to detail as well as strong process execution and analytical skills.
Experience with driving change management initiatives is required.
Knowledge of Pyxis products, Dispensing Professional Services implementation processes and/or Dispensing Service/Support processes, is preferred.
Job Description We are the makers of possible.
BD is one of the largest global medical technology companies in the world.
Advancing the world of health™ is our Purpose, and it's no small feat.
It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve.
Join us and discover an environment in which you’ll be supported to learn, grow and become your best self.
Become a maker of possible with us.
*** This position can be a REMOTE position, with Hybrid as an option.
*** Location: prefer San Diego candidate or candidate located in Pacific or Mountain Time Zones.
Key responsibilities: Actively participates in GCS compliance initiatives with Readiness and Quality project teams.
Leads projects as appropriate.
For GCS Dispensing CAPAs, leads assigned CAPAs which includes facilitating the team of SMEs to meet CAPA requirements on schedule and per CAPA guidelines.
Leads up-classification workstreams for GCS, including support for Design Inputs/Outputs, Labeling, device traceability, etc.
Creates and maintains GCS procedures, work instructions, and GCS documentation.
Identifies opportunities to streamline or improve processes Professional Skills & Key Competencies Ability to manage multiple projects, lead cross functional teams, and work independently with minimal supervision Excellent writing skills and the ability to communicate correctly and concisely in English Strong customer service skills and positive attitude Comfortable working with ambiguity Advanced skills with Microsoft Office products Ability to meet tight deadlines and handle changing priorities Desired/Additional Skills & Knowledge: Bachelor’s Degree in Engineering, Technology, or Life Sciences preferred or 7 years equivalent work experience.
Seven or more years of experience in project management; PMP preferred Prior experience within a regulated industry (e.
g.
, medical device, pharma, automotive, aerospace) is preferred Managed/supported projects cross-functionally in an iterative, fast paced environment Excellent verbal and written communication skills required Strong analytical, problem-solving, and interpersonal skills Strong leadership and group facilitation skills; experience leading and influencing in a matrix managed environment High attention to detail while managing multiple complex deliverables and stakeholder groups Ability to learn quickly, deal with ambiguity, take initiative and achieve results Demonstrated proficiency with MS Office skills, particularly in PowerPoint, Excel, and Word.
Proficiency with SharePoint, Jira, and Confluence preferred.
Proven organization and time management skills Travel: up to 15% Location: prefer San Diego candidate or candidate located in Pacific or Mountain Time Zones For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19.
In some locations, testing for COVID-19 may be available and/or required.
Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We welcome people with the imagination and drive to help us reinvent the future of health.
At BD, you’ll discover a culture in which you can learn, grow, and thrive.
And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.
com/careers Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN Primary Work Location USA CA - San Diego Bldg A&B Additional Locations Work Shift At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.
We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility.
There are many factors, such as location, that contribute to the range displayed.
The salary offered to a successful candidate is based on experience, education, skills, and actual work location.
Salary ranges may vary for Field-based and Remote roles.
Salary Range Information $104,900.
00 - $173,000.
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